Average Patient Weight Research Articles

Ghrelin and Leptin Changes Post-Sleeve Gastrectomy

Background: Ghrelin and leptin may regulate metabolism and appetite. Ghrelin, a newly discovered orexigenic gastric hormone, is produced when the stomach is empty. This may explain why morbidly obese people fail to diet, hence the recommendation for bariatric surgery. Leptin, a well-known adipokine, inhibits food intake and circulates at fat-mass-related levels. Aim of the study: To evaluate changes in the ghrelin and leptin level post-laparoscopic sleeve gastrectomy. And their relation to changes in appetite and weight loss. Methods: This prospective study examines adult patients' clinical and lab data for pre- and post-sleeve gastrectomy at Al-Hussain Medical City and Al-Kafeel Hospital in Karbala. The study included 48 obese individuals (36 females and 12 males) with a mean age of 35.5 ± 8.9 years and a BMI of 42.4 ± 5.6 kg/m2. Clinical data comprised pre-surgery body weight, height, hunger, and ghrelin and leptin levels. Patients were seen 2–5 months following surgery for follow-up. Results: Significant decreases in plasma ghrelin (p<0.0001) and leptin (p<0.0001) were detected. Patients reported a considerable appetite reduction post-surgery (p <0.0001). Serum ghrelin (p = 0.0004) and leptin (p = 0.003) decreased significantly compared to hunger fluctuations following surgery. The average patient weight loss was 20.2 kg, and excess weight loss was 36.4 ± 10.8%. All patients achieved an 8 kg/m2 weight loss and a 46 ±16.6% excess weight loss while controlling comorbidities such as diabetes, hypertension, and sleep apnea. Conclusion: Significant reduction in ghrelin and leptin levels post-surgery. Significant correlation between decrease in ghrelin and leptin concentrations and decrease in appetite post sleeve gastrectomy.

A cost comparison of pembrolizumab: Fixed and weight-based dosing.

Pembrolizumab, an immune checkpoint inhibitor, indicated to treat multiple cancers, was initially approved in Australia as weight-based dosing at 2 mg/kg every 3 weeks (Q3W). Subsequent approvals used 'fixed' dosages of 200 mg Q3W or 400 mg every 6 weeks (Q6W). Pharmacokinetic equivalence was demonstrated between dosing strategies, with no significant differences in efficacy or toxicity. Fixed dosing regimens are routinely used in Australia. To model and compare the cost of weight-based dosing of pembrolizumab to standard fixed dosing regimens. A single centre, retrospective review was conducted. Patients, identified from dispensing software, who commenced on pembrolizumab between January and December 2022 were included. Patient demographic and treatment data was extracted from electronic medical records. Costs of weight-based doses were calculated and compared to the cost of fixed dosing. Variables such as acquisition cost, funding mechanisms and 'vial sharing' were considered. Fifty-two patients were included (63% male, median age 68 years). Of the 211 doses of pembrolizumab administered (average 4.1 doses/patient), 161 were Q3W doses, and 50 were Q6W doses. The acquisition cost for a fixed 200 mg and 400 mg dose was $7646, and $15,292, respectively. The average patient weight was 77.6 kg (SD 19 kg), which equated to $5933 for a weight-based Q3W dose, and $11,867 for the Q6W dose; a potential cost avoidance of $1965 and $3930 per dose, respectively. This represented a possible 23.5% avoidance in medication acquisition cost. Over the study period of 1 year, using weight-based dosing for pembrolizumab had the potential to reduce medication expenditure by $467,996. Significant cost avoidance could be achieved via weight-based pembrolizumab dosing. Given the substantial total cost of pembrolizumab, the growing number of indications and the expected equivalent treatment outcomes with weight-based pembrolizumab, the potential cost reductions of weight-based pembrolizumab at both institution and government level should be further explored.

Analysis of bisphenol-propane in dialyzer and its effect on human body

The effect of trace solvent bisphenol A (BPA) in polyether sulfone hollow fiber membrane Enttex™-16LF (E60) (produced by 3 M) low-throughput dialyzer was tested in this study. Animal experiments were conducted to evaluate its genotoxicity, carcinogenicity, and teratogenicity upon chronic exposure. The dialyzer was operated at 200 mL/min and 400 mL/min and coupled with LC-20AT liquid chromatography to detect BPA, which showed that the BPA content was less than 5 μg/kg/d at both flow rates. In animal experiments, the tolerable intake (T.I.) was calculated to be 0.5 μg/kg/d. With hemodialysis three times per week, the average patient weight was calculated at 70 kg, and the average daily BPA exposure was 0.0306 μg/kg/d. The risk of residual BPA was within the acceptable limit with polyether sulfone membrane Enttex™-16LF (E60) hollow fiber dialyzer from 3 M, without inducing risk for disability, teratogenicity, or genotoxicity.

Medial Structures at Risk During Sinus Tarsi Approach for Fixation of Sustentaculum Tali Fractures: A Cadaveric Study

Category: Hindfoot; Trauma; Other Introduction/Purpose: Calcaneal fractures are a common injury with potential for concomitant involvement of the sustentaculum tali. Common surgical repair involves a sinus tarsi approach with placement of a lag screw from lateral to medial. There is no current study that focuses on the potential damage to the medial structures after screw placement. The goal of this paper was to describe the incidence in which medial structures were damaged using a sinus tarsi approach for lateral to medial screw fixation of the sustentaculum tali. Methods: Seven fresh-frozen below-the-knee cadaver specimens were used for the present anatomic dissection study. Prior to investigations, specimens were inspected with fluoroscopic radiographs for any pathology or prior operational intervention Each specimen underwent screw placement using the sinus tarsi approach. Medial dissection of the calcaneus was performed after screw placement to determine the proximity of the anatomical structures of interest to the inserted hardware. The four anatomical structures of interest were the tibialis posterior tendon, flexor hallucis longus, flexor digitorum longus, and posterior neurovascular bundle. Distance from the 4.0 mm screw to the previously mentioned anatomic structures was measured with a scientific ruler and recorded to the nearest millimeter. The mean, standard deviation, and range for distances were calculated for all structures. Analysis of variance (ANOVA) was used to determine statistical significance. Results: The average patient age, height, and weight were 79.3 years, 5 feet 4 inches, and 127 lbs respectively. The primary outcome of interest was the longitudinal distance between the medial aspect of the screw to the anatomical structures of interest. On average, the posterior neurovascular bundle had the closest proximity to the medial aspect of the screw for all seven specimens with a mean distance of 6.4 mm. The second closest structure was the FHL with a mean distance of 7 mm, followed by the FDL and tibialis posterior tendon, with mean distances of 9.9 mm and 13.9 mm respectively. The posterior neurovascular bundle was hit by the screw on one occasion, whereas the hardware contacted the FDL on two separate occasions. The screw was placed through the FDL in one of the two occasions; however, the FDL was not transected or ruptured. Conclusion: This study sheds more light on the potential risks to medial structures when placing the sustentacular screw during open reduction and internal fixation of displaced intraarticular calcaneal fractures. We urge the orthopedic surgeon to exercise extreme caution when performing this critical step of the procedure to minimize avoidable injury to structures of importance that may increase the morbidity of the patient.

Prelude to PATHWEIGH: pragmatic weight management in primary care.

Treatment of obesity-related diseases, rather than obesity itself, remains the mainstay of medical care. The current study examined a novel approach that prioritizes weight management in primary care to shift this paradigm. PATHWEIGH is a weight management approach consisting of staff team training, workflow system management, and data capture from tools built into the electronic medical record (EPIC). PATHWEIGH was compared to standard of care (SOC) using two family medicine clinics in the same US healthcare system. Descriptive statistics compared patient-, provider-, and clinic-level factors between the groups among those with at least one weight-prioritized visit (WPV) and one follow-up weight over 14 months. Groups were similar in terms of total patient visits (7,353 vs. 7,984) and patients eligible for a WPV (i.e. >18 years + body mass index >25 kg/m2; 3,746 vs. 3,008, PATHWEIGH vs. SOC, respectively). However, more PATHWEIGH clinic patients (15.9% vs. 8.4%; P < 0.001) received at least one WPV. Although no difference was observed for average patient weight loss over 14 months (P = 0.991), the number of WPVs per patient was higher in PATHWEIGH (P < 0.001) and significantly associated with weight loss (P = 0.001), with an average decrease in weight of 0.55 kg per additional visit. Results from the current study demonstrate early success in changing the paradigm from treating weight-related comorbidities to treating weight in primary care.

Postoperative Complications of Esophageal Atresia and Role of Endoscopic Balloon Dilatation in Anastomotic Strictures.

Esophageal atresia (EA) with or without tracheoesophageal fistula (TEF) is a congenital anomaly that can cause frequent digestive and nutritional problems, even after repair. The most common complication is anastomotic stricture, for which reoperation or balloon dilatation is performed. This study aimed to evaluate the postoperative complications of EA and the role of endoscopic balloon dilatation (EBD) in cases of anastomotic stricture. We retrospectively analyzed patients diagnosed with EA with or without TEF between January 2000 and February 2021. Patients' baseline characteristics, associated anomalies, and postoperative complications were reviewed. Among 26 patients, 14 (53.8%) were male, 12 (46.2%) had coexisting anomalies, and the median follow-up was 6.1 years (range, 1.2-15.7 years). In univariate analysis, prematurity, low birth weight, and long-gap EA were associated with postoperative complications in 12 (46.2%) patients. Among the 10 (38.5%) patients with anastomotic stricture, nine (90.0%) required EBD. Regarding the first EBD, it was performed at a median of 3.3 months (range, 1.2-7.6 months) post-repair, while the average patient weight was 4.6 kg. The mean diameter ranged from 3.3 to 9.1 mm without major complications. In univariate analysis, long-gap EA alone was significantly associated with EBD. Approximately half of the patients experienced complications after EA repair. In particular, patients with a long-gap EA had a significantly increased risk of complications, such as anastomotic strictures. EBD can be safely used, even in infants.

Endoscopic revision of gastrojejunal anastomosis for the treatment of dumping syndrome in patients with Roux-en-Y gastric bypass: a systematic review and meta-analysis.

Dumping syndrome is a known complication of Roux-en-Y gastric bypass (RYGB). Recently, endoscopic gastrojejunal anastomosis (GJA) revision has been employed as a treatment option. The primary aim of this study was to perform a systematic review and meta-analysis for the role of endoscopic GJA revision in patients with RYGB for the treatment of dumping syndrome. Search strategies were developed for PubMed, EMBASE, Web of Science, and Cochrane Library databases from inception through December 2020 in accordance with PRISMA and MOOSE guidelines. Pooled proportions with rates estimated using random effects models were used. Outcomes included pooled technical success, clinical success, adverse events, and rate of reintervention. Heterogeneity was assessed with I2 statistics and publication bias by funnel plot using Egger and Begg tests. Six studies (n = 263 patients; 60.25% female) were included (1 prospective and 5 retrospective). Mean age was 46.27 ± 2.54years. Average patient weight was 95.59 ± 4.78kg, BMI of 41.43 ± 3.07kg/m2, and pre-procedure GJA size of 32.23 ± 8.68mm. Pooled technical and clinical success was 98.15% and 89.5%. Among studies reporting Sigstad scores, endoscopic GJA revision resulted in a significant improvement [mean Sigstad score difference of -9.96 (95% CI, -19.951 to -0.975); P < 0.03]. Mean procedure time was 37.12 ± 10.40min with an intra-procedural adverse event rate of 2.42%. Over a mean follow-up of 8.03 ± 6.87months, post-procedure adverse events occurred in 2.96% of patients with a reintervention rate of 11.54%. This systematic review and meta-analysis suggests that endoscopic GJA revision appears an effective and safe treatment for dumping syndrome.

Visualization of the renal artery in kidney transplant patients using time-resolved computed tomography angiography

BackgroundTransplant renal artery stenosis (TRAS) is a post-operative complication which most often occurs between 3 months and 2 years after transplantation. TRAS is associated with kidney failure and hypertension and, thereby, with an increased risk of cardiovascular events.PurposeThe purpose of this retrospective study was to report our experience of perfusion computed tomography angiography (P-CTA) to identify a 50% lumen reduction (as compared to digital subtraction angiography, DSA), assess its subjective image quality and evaluate if contrast-induced acute kidney injury (CI-AKI) occurred.Material and MethodsAll 13 patients who had undergone P-CTA for suspected TRAS at our institution were retrospectively evaluated. At P-CTA, eight or 12 g of iodine were administered intravenously, and five to seven scan sequences were merged into time-resolved images after motion correction. Eight patients underwent subsequent DSA.ResultsThe average patient weight was 76 kg (range 55–97 kg). Image quality was rated as good or excellent for all patients, and pathological changes were shown in 10 of 13 patients undergoing P-CTA. Two patients had a serum creatinine increase of >26 μmol/L during the first 3 days, but serum creatinine was significantly lower in all patients 1 month after P-CTA (165+/−69 μmol/L versus 232+/−66 μmol/L, P < .01). The diagnosis at P-CTA was verified in all eight patients who underwent DSA. However, in two cases with suspected stenosis, renal function was restored without angioplasty.ConclusionAnatomy and blood flow of the transplant renal artery can be visualized using less than a third of the standard contrast media dose by using P-CTA technique.

Risk of adverse events due to high volumes of local anesthesia during Mohs micrographic surgery.

General guidelines for the maximum amounts of locally injected lidocaine exist; however, there is a paucity of data in the Mohs micrographic surgery (MMS) literature. This study aimed to determine the safety and adverse effects seen in patients that receive larger amounts of locally injected lidocaine. A retrospective chart review of 563 patients from 1992 to 2016 who received over 30mL of locally injected lidocaine was conducted. Patient records were reviewed within seven postoperative days for complications. The average amount of anesthesia received was 40mL, and the average patient weight was 86.69kg. 1.4% of patients had a complication on the day of surgery, and 4.4% of patients had a complication within 7 days of the surgery. The most common complications were excessive bleeding/hematoma formation and wound infection. Only two complications could be attributable to local anesthetics. Gender, heart disease, hypertension, diabetes, and smoking were not significant risk factors for the development of complications. MMS is a safe outpatient procedure for patients that require over 30mL of locally injected anesthesia. The safety of high volumes of lidocaine extends to patients with risk factors such as heart disease, hypertension, diabetes, and smoking.

Experience of Management of Anorexia Nervosa Patients with Extremely Severe Malnutrition in a Transdisciplinary Clinical Nutrition-Eating Disorders Inpatient Unit

Background: The question of where to hospitalize extremely malnourished patients with anorexia nervosa (AN) is a real dilemma. On one hand, psychiatrists have to deal with severe medical complications that are not within their competences and that justify hospitalization in an internal medicine ward. On the other hand, medical doctors have to face psychic decompensations that would justify admission to a psychiatric ward. In this context, we share our experience of management of severely malnourished AN adult patients in a transdisciplinary specialized eating disorders (ED) unit, referral center for AN associated with somatic severity. Method: First, we described the modalities of care proposed to patients with AN hospitalized in the medical unit. Intensive medical care, both somatic and psychiatric, are provided thanks to a transdisciplinary therapeutic program, where objectives are to: medically stabilize the patient, initiate progressive refeeding and start supportive psychotherapy before being transferred to a psychiatric ED unit. Secondly, we conducted a retrospective descriptive study that included all adult patients with AN admitted for the first time to the unit, between November 1997 and January 2014, for severe malnutrition and/or complications of the ED. Objective was to specify patients’ characteristics: demographic, nutritional status, history of ED, care pathway. Results: Among a cohort of 386 adult patients with AN (21 males and 365 females) admitted for the first time in the unit, mean age was 29.4 (±11.5) years, mean BMI was 12.7 (±2.2) kg/m2. Before being supported in the unit, 78.2% of patients had already been hospitalized in other hospitals. Mean length of stay was 35.2 days. Patients were clinically serious and unstable because of life-threatening somatic complications due to a low BMI. During hospital stay, a temporary transfer to medical intensive care unit was necessary for 25.6% of patients. Average patient weight gain was 0.777 kg per week and 81.9% of patients benefited from enteral nutrition. Conclusion: This specialized transdisciplinary unit where physician nutritionists and psychiatrists coordinate medical care together, allow a better understanding and management of extreme malnutrition associated with AN. Thanks to their expertise, care teams are less critical and less rejecting towards patients. Thus, therapeutic alliance could be optimized.

Cost-minimization analysis of biological disease-modifying antirheumatic drugs in the Brazilian public health system (SUS) considering patients’ weight

Objective: To perform a cost-minimization analysis comparing the cohort with the current average patient weight of 70 kg (MoH current assumption). Since most rheumatoid arthritis (RA) patients in Brazil are women (60 kg or less), we also aimed to define this percentage at Brazilian public healthcare system (SUS). Methods: Treatment-naïve RA patients using biologics from January 2008 to November 2018 were retrieved from Datasus as well as the number of patients ≤ 60 kg and their drug use distribution. Data on drug costs were assessed from the last payment reported by MoH and then recalculated using the weighted average of 60 kg and a 52-weeks a year to assess cost-minimization. Results: In the studied cohort, 33,646 patients (33.3%) were classified as ≤ 60 kg. Annual cost per patient, considering an average weight of 60 kg, ranged from 2,872,29 USD to 4,223.93 USD. Tocilizumab 80 mg was the only drug demonstrating a reduction in annual cost per patient (-526.79 USD). Conclusion: Cost-minimization analysis based on weight-dependent dosage showed that tocilizumab could reduce MoH costs with RA treatment in 14.28%. By adopting weight-dependent dose of 60 kg, the Brazilian government could save up to 916,651.31 USD per year using tocilizumab versus other biological disease-modifying antirheumatic drugs (DMARDs). In ten years, it represents an accumulative saving of 9,166,513.57 USD.

Diagnostic Reference Levels for conventional radiography and fluoroscopy in Austria: Results and updated National Diagnostic Reference Levels derived from a nationwide survey

ObjectiveEvaluation and updating of Austrian National Diagnostic Reference Levels (NDRLs). MethodsA nationwide survey on common conventional radiography and fluoroscopy examinations was conducted. In line with Austrian radiation protection standards, all relevant Austrian hospitals and radiology offices/centers were asked to report a minimum sample of 10 representative dose-area product (DAP) values together with patient weight and fluoroscopy time, if applicable. Examinations included for conventional radiography were skull, chest, abdomen, pelvis, lumbar spine and bedside chest x-ray, for fluoroscopy barium enema (single and double contrast) and swallowing (video). Participants were invited via e-mail, followed up by reminders to increase participation rates. Plausibility checks were performed to increase data quality. 3rd quartiles of facility median and mean DAP were calculated and compared to Austrian and international NDRLs. Results59% of invited facilities submitted DAP data, 43% submitted additional data on patient weight and 41% on fluoroscopy time. DAP case numbers varied from 1005 to 2121 for conventional radiography and from 182 to 1380 for fluoroscopy. Average patient weight was 75 kg for conventional radiography and 77 kg for fluoroscopy. Conclusion3rd quartiles derived from the survey are substantially lower than the old Austrian NDRLs (valid till early 2018). Since 3rd quartiles correspond well to European NDRLs, the update would be in accordance with European DRL harmonisation efforts.

Clinical and Paraclinical Profile of People Living with Human Immunodeficiency Virus on Second Line Treatment in Kinshasa, Democratic Republic of Congo

Context: For the year 2018, the Provincial Division of the National Program for the Fight against HIV/AIDS and Sexually Transmitted Diseases published for the city of Kinshasa a total of 58,327 People Living with HIV (PLHIV) on Antiretroviral Treatment (ART) of which 5,789 (9.9%) were on second-line ART. Objective: The objective of this study was to determine the clinical and paraclinical profile of people living with HIV on second-line treatment followed in Kinshasa. Methods: The present study was an exploratory cohort study to evaluate the profile of PLHIV on second-line of treatment in Kinshasa. All PLHIV confirmed on first-line treatment failure and second-line ART were selected for this study. The clinical and paraclinical parameters were recorded from the individual files of the patients selected on inclusion (D0) and after 6 months of treatment (M6). Viral Load (VL) determination was done by PCR on Abbott m2000rt and CD4 cell count was determined using BD Facs Count. The clinical and paraclinical parameters of M6 were compared with those taken on D0. Results: 50 patients were selected for this study based on the inclusion criteria. 27 patients (54%) were women. The age of the patients was between 18 and 82 years with an average of 50.5 ± 11.75 years. The dominant age group was of 46 to 55 years with 18 patients (36%). At inclusion, the mean duration of treatment under the 1st line was 35 ± 8 months of ART. Thirty-eight patients (76%) were on clinical stage 3 for HIV infection according to the World Health Organization (WHO) classification. The average patient weight on D0 was 54.36 ± 13.70 kg; the median value of CD4 was 217 cells/μl. At M6, 32 patients (64%) were in clinical stage 3; the average patient weight was 60.34 ± 13.07 kg. The median CD4 value on M6 was 371 cells/μl. The median value of the Viral Loads (VL) of the patients was 0 RNA copies/ml. After 6 months of ART, 36 patients (72%) experienced significant weight gain; 7 patients (14%) showed an improvement in their clinical status. 41 patients (82%) had an increase in baseline CD4 count and 31 patients (62%) had a VL less than 200 RNA copies/ml. Conclusion: Patients on second-line ART start treatment with a significantly higher average age. Biological parameters are systematically higher in general. After 6 months of ART, the second-line ART failure rate was estimated at 38% with a population with a visible weight gain.

PSY85 - Cost Minimization Analysis of Generic Versus Brand Form of Deferasiroix N The Management of B-Thalassemia Patients with Chronic Iron Overload: An Egyptian Health Care Provider Perspective

In Egypt, B-thalassemia creates financial burden on the patients’ family and the society. Iron overload is a common clinical problem, arising from long-term transfusion therapy which is required to improve life expectancy for B-thalassemia patients. Iron chelation therapy is often used to remove excess stored iron and to reverse related complications including hepatic, endocrinological and cardiac dysfunction. The aim of this study was to perform a cost minimization analysis (CMA) of generic versus brand form of Deferasirox in the management of B-thalassaemia patients with chronic iron overload from the health care provider perspective. Direct medical costs were reported in Egyptian pounds of the financial year 2016. The doses were calculated for an average patient weight of 30.5 kg. Discounting was needed as costs were calculated for a time horizon of 20 years. One way sensitivity analysis was conducted and all the variables were varied with a range of ±10%. Total costs for generic and brand form of Deferasirox were EGP 19,454,775 and EGP 29,038,688, respectively. This study revealed that the generic form of Deferasirox is the least expensive drug when compared to it'seems brand form in the management of B-thalassaemia patients with chronic iron overload from the health care provider perspective. One way sensitivity analysis showed that the costs of drugs have the highest impact on the results. The generic form of dferasirox is the preferred drug compared to its brand form in the management of B-thalassaemia patients with chronic iron overload from the health care provider perspective.

The effect of vancomycin powder on bone healing in a rat spinal rhBMP-2 model.

OBJECTIVE This study aims to quantify the impact of vancomycin powder application on new bone formation and spine fusion rates in a rat posterolateral arthrodesis model. METHODS Thirty-six female Sprague-Dawley rats underwent a posterolateral lumbar spinal fusion (PLF) at the L-4 and L-5 vertebrae. Fusion was elicited via implantation of an absorbable collagen sponge containing 3 µg rhBMP-2. Rats were divided into 3 groups: no vancomycin (control), standard-dose vancomycin, and high-dose vancomycin, based on what was applied to the fusion bed. Clinical studies typically describe the application of 1 g vancomycin into the surgical wound. Presuming an average individual patient weight of 70 kg, a weight-based equivalent dose of vancomycin powder was applied subfascially in the PLF model constituting a "standard-dose" treatment group (14.3 mg/kg, n = 12). To determine whether there is a critical threshold beyond which vancomycin increases the risk of pseudarthrosis, a 10-fold higher dose was administered to a "high-dose" treatment group (143 mg/kg, n = 12). No vancomycin powder was applied to the surgical site in the control group (n = 12). Fusion was evaluated with plain radiographs at 4 and 8 weeks after surgery. The spines were harvested after the 8-week radiographs were obtained and evaluated using manual palpation, microCT analysis, and histological analysis. RESULTS Radiographs demonstrated equivalent bridging bone formation in all groups. No significant differences in fusion scores were seen in the standard-dose (mean 2.25) or high-dose (2.13) treatment groups relative to untreated control animals (1.78). Similarly, fusion rates did not differ significantly different between vancomycin-treated animals (100% for both groups) and control animals (92%). Quantification of new bone formation via microCT imaging revealed no significant between-groups differences in the volume of newly regenerated bone (control vs standard-dose vancomycin, p = 0.57; control vs high-dose vancomycin, p = 0.53). CONCLUSIONS This is the first in vivo study to specifically address the development of pseudarthrosis after intrawound application of vancomycin during fusion surgery. Our results demonstrate that vancomycin powder does not inhibit fusion rates at a dose that is the weight-percentage equivalent of what is routinely used by surgeons. Moreover, bone formation and fusion rates were not reduced even after administration of a vancomycin dose that is 10-fold higher than that which is typically administered clinically. Our findings suggest that if there is a critical threshold above which vancomycin inhibits bone healing, such a dose is out of the range which might be considered reasonable for clinical use.

PIN66 - Cost-Effectiveness Analysis of Anidulafungin In the treatment of Candidemia In Chile

Candidemia incidence in Chile has been estimated around 0.33 (0.21–0.47) per 1,000 admissions. The aim of this analysis is to assess the cost-effectiveness of anidulafungin compared with currently licensed antifungal agents in the treatment of confirmed infection of candidemia or invasive candidiasis in Chile. The analysis was made from third payer perspective; the model timeframe was within a 6-week inpatient follow-up period with an extrapolation to lifetime for those surviving the 6-week period. Non-neutropenic patients were assumed. A tree-decision model was used to estimate potential treatment costs of anidulafungin vs comparator agents. Clinical success, mortality and adverse events rates were taken from international literature. Drug costs were taken from local institutional report and nephrotoxicity cost from official document, considering hemodialysis as required procedure. Comparators were: anidulafungin (loading dose 200mg/day, maintenance 100mg/day), caspofungin (loading dose 70mg/day, maintenance 50mg/day), micafungin (100mg/day), fluconazole (400mg/day), voriconazole (loading dose 6mg/kg/twice daily, maintenance 200mg twice daily or 4mg/kg twice daily), conventional amphotericin B [CAMB] (1 mg/kg), and liposomal amphotericin B [LAMB] (3mg/kg/day). It was considered an average patient weight of 76.4 kg (SD 25.5kg). Results are expressed as incremental cost-effectiveness ratio (ICER) US$ per life year gained (LYG) in 2014 US$ (exchange rate US$1=CLP$600). Total costs (drugs and hospital stay) associated with the treatment were: CAMB US$18,664; fluconazole US$15,327; micafungin US$17,210; voriconazole US$17,310; anidulafungin US$17,941; caspofungin US$18,619; LAMB US$24,794; number of life years gained were: 6.30, 6.52, 5.55, 6.77, 7.23, 6.03 and 5.47, respectively. Caspofungin, Amphotericin B and LAMB were dominated by anidulafungin; ICER of anidulafungin compared to fluconazole, micafungin and voriconazole was US$3,729; US$436 and US$1,371, respectively. For the analyzed scenario with threshold per life-year gained over US$3,729, anidulafungin is a cost-effectiveness therapy compared to micafungin, fluconazole, voriconazole and generates savings compared to CAMB, caspofungin and LAMB for candidemia in Chile

Analysis of Using Low Dose 3 Factor PCC (Bebulin®) for INR Reversal in Patients with Warfarin Induced Severe/Life-Threatening Bleeding

Background: 3 Factor Prothrombin Complex Concentrates have been used off label with plasma products for effective and timely reversal of INR in patients on Warfarin presenting with severe bleeding. The exact dosage required for this purpose has yet to be determined.Methods: We conducted a retrospective review of all patients taking Warfarin who presented to our institution between January 1, 2013 to June 30, 2014 who received 3 Factor Prothrombin Complex Concentrate (PCC) Bebulin® for INR reversal for significant/lifethreatening bleeding. The dose of Bebulin was determined by clinical judgment by the blood bank and the treating physician in accordance with the patient’s weight, bleeding location and the presenting INR.Results: A total of 116 patients were treated. Mean age was 72 years. Forty-two (36.21%) of patients were female. Most common bleeding site was intracranial (n=61), followed by systemic hemorrhage (n=24), GI bleeding (n=16), trauma (n=10) and other bleed (n=5). Some patients were also on other anticoagulants besides Warfarin – 28 patients (24%) were on Aspirin and 9 (7.8%) on Plavix. The mean INR prior to Bebulin treatment was 3.62 which dropped to 2.05 at an average of 2.2 hours post-treatment. Mean level at 12 hour post-Bebulin dropped to 1.57. The average patient received 2 units of plasma and 1 unit of packed red cell transfusions. The average Bebulin dose administered was 959 IU (SD +/-465 IU) with average patient weight of 82.9 kg (SD +/- 27kg). Based on this the average Bebulin dose administered was 11.57 IU/kg. Eighty-eight patients (76%) were able to be discharged home or to a skilled nursing facility.Thirty-six patients (31.1%) required more than one dose of Bebulin®. Mean INR at presentation in this group of patients were not similar to the remainder of the group. Mean INR at average of 2.5 hours post-Bebulin in this group was 2.18 which dropped further to an average of 1.75 at 9 hours. The total average Bebulin dose incrementally administered was similar in both groups.Conclusion: Low dose Bebulin at doses of approximately 12 IU/kg with 2 Units of plasma was effective in timely reversal of INR in majority of patients who presented with Warfarin induced bleeding. DisclosuresOff Label Use: Bebulin (3 Factor PCC) is approved for use in Hemophilia patients; we discuss using low dose for INR reversal in Warfarin associated bleeding.

Postmarketing review of intravenous acetaminophen dosing based on Food and Drug Administration prescribing guidelines.

To evaluate the appropriateness of intravenous acetaminophen dosing-prescribed dose, frequency, duration, and indication-based on United States Food and Drug Administration (FDA)-approved prescribing guidelines and to evaluate the adverse effect profile of intravenous acetaminophen. Retrospective chart review. United States Navy medical center. Three hundred patients who received intravenous acetaminophen from August 1, 2011, to August 1, 2012. The indications, dose, frequency, and duration of intravenous acetaminophen were recorded for each patient. Adverse effects of intravenous acetaminophen were analyzed by thoroughly reviewing any adverse effects documented, including nausea, vomiting, headache, or any symptom specifically attributed to the drug. Baseline liver function tests, including aspartate aminotransferase and alanine aminotransferase levels, and elevations 3 times the upper limit of normal during intravenous acetaminophen therapy were recorded. The average patient weight was 78±21 kg, with 12 patients (4%) weighing less than 50 kg and 288 (96%) patients weighing 50 kg or greater. Two hundred forty-one patients (80%) were appropriately dosed, whereas 59 (20%) patients were not appropriately dosed based on the FDA-approved dosing. No patients exceeded the FDA-approved maximum daily dosing recommendations for intravenous acetaminophen (4 g). Sixty-five patients (22%) received intravenous acetaminophen for longer than 24 hours. Intravenous acetaminophen was well tolerated, without any reported adverse effects, including the commonly reported adverse effects of nausea, vomiting, headache, and insomnia. Ten patients (3%) had a documented history of liver disease and did not experience any adverse effects or increases in liver function tests after the administration of intravenous acetaminophen. Intravenous acetaminophen appeared to be a safe and effective analgesic and antipyretic agent. Dosing for patients weighing less than 50 kg needs to be appropriately weight adjusted. Intravenous acetaminophen can be used alone or in conjunction with opioids and other analgesics. Limitations of this study include its retrospective design, inability to assess outcomes of reducing opioid use, and short-term observation period.

Dietary intake and ghrelin and leptin changes after sleeve gastrectomy.

IntroductionSurgical intervention in obesity is today the most effective treatment method in high level obesity management. Bariatric interventions not only ensure body weight reduction, but may influence dietary habits.AimTo assess changes in adipose hormones and dietary habits in obese patients after sleeve gastrectomy.Material and methodsThe study set comprised 37 subjects (29 females and 8 males) 24 to 68 years old with body mass index 43.0 ±4.9 kg/m2. Pre-operative examination included baseline measurements of body composition. Dietary habits and intake frequency were monitored by a questionnaire method. Follow-up examinations were carried out in a scope identical to the pre-operative examination, 6 and 12 months after surgery, respectively.ResultsThe average patient weight loss 12 months after surgery was 31.7 kg. Excess weight loss was 55.2 ±20.6%. Patients reported reduced appetite (p < 0.001), increasingly regular food intake (p < 0.001), intake of more meal portions per day (p = 0.003) and a decrease in consuming the largest portions during the afternoon and evening (p = 0.030). Plasma levels of fasting glucose, leptin and ghrelin significantly decreased (p = 0.006; p = 0.0.043); in contrast, the level of adiponectin significantly increased (p < 0.001).ConclusionsSleeve gastrectomy and follow-up nutritional therapy resulted in a significant body weight reduction within 1 year after surgery. An improvement of certain dietary habits in patients was registered. At 12 months after surgery, there were no statistically significant differences in decreases in ghrelin and leptin concentrations between patients without changed appetite and those reporting decreased appetite.

Moving away from benzodiazepine as a primary sedative in the intensive care unit; is clonidine a viable alternative?

Current pain, agitation, and delirium (PAD) guidelines endorse a benzodiazepine-sparing approach to aid in achieving optimal patient outcomes.[1] Several benzo-sparing strategies, including protocolized and frequent pain, sedation and delirium assessments, achieving the goal of awake and alert, utilization of bolus and symptom-triggered, patient-specific pharmacotherapy, interruption of sedatives, a pain-first approach or analagosedation, early mobilization, rotation of medications, and adjustment of ventilator settings are nonmedication specific principles shown to improve clinical outcomes in mechanically ventilated (MV), intensive care unit (ICU) patients. These techniques and strategies have been associated with some of the most relevant clinical outcomes including a decrease in discomfort, ventilator-associated pneumonia, length of MV, and ICU and hospital length of stay.[2,3] Interestingly, extremely few well-conducted sedative versus sedative trials show improvements in these hard clinical outcomes. Dexmedetomidine is an effective agent for PAD management and a viable alternative to benzodiazepine therapy. Dexmedetomidine maintains a light level of sedation, while minimizing the deep sedation commonly seen with benzodiazepines. In randomized, controlled trials, dexmedetomidine has been associated with shorter duration of delirium and MV compared to benzodiazepine infusion, specifically midazolam.[4] It should be noted, however, that these trials showing a reduction in MV duration are not without criticism. For example, the mean dose of midazolam in the SEDCOM trial was approximately 5 mg/h (based on the average patient weight of 88 kg); an extremely high dose by clinical standards when the goal is to keep a patient awake and alert.[5] Dexmedetomidine is relatively safe with fairly predictable cardiovascular (CV) effects (most frequently hypotension and bradycardia). These CV risks can often be mitigated by avoiding the use of bolus therapy and extending titration intervals to no more frequently than every 30 min.[6] The cost of dexmedetomidine is often a concern in many parts of the world. There are several strategies to address the cost of dexmedetomidine including use of alternative medication or by following restrictive institution specific guidelines. A recent publication on dexmedetomidine stewardship showed an institution's approach to managing the benefits of the drug versus the cost. The guideline followed in this analysis supports judicious use of dexmedetomidine in patients who fail traditional therapy.[7] Another important note in terms of cost is in certain parts of the world dexmedetomidine will lose its patent in the near future and is likely going to be price reduced. We commend the investigators for their fine analysis entitled “comparison of clonidine and dexmedetomidine for short term sedation of ICU patients” published in this month's journal.[8] This trial examined the efficacy and safety of clonidine as an alternative to dexmedetomidine in MV patients. The authors conclude both agents are effective, although clonidine is associated with a higher risk of hypotension. This paper adds to the literature suggesting clonidine may be a useful medication for PAD management although further investigation is needed to confirm these findings. We support the author's conclusion although we think there are some key critiques of this analysis. (1) The authors assessed and titrated to Ramsay Sedation Score (RSS) but pain and delirium assessment scores were not reported. Therefore, it is hard to tell if the pain-first approach was employed prior to the use of either sedative. (2) The goal RSS in this trial was 3-4 yet an RSS of 5, corresponding to awake and alert, may have been a more appropriate goal and these patients may have been more deeply sedated than would be desired in clinical practice. (3) Dexmedetomidine performed better statistically than clonidine, therefore lumping them both as effective may be slightly misleading. It is also important to note that the relatively high incidence of hypotension in the clonidine arm is concerning. A recent trial published on clonidine in noncardiac surgery patients highlights safety concerns with a troubling increase in clinically important hypotension and nonfatal cardiac arrest.[9] Although a different patient population than this study, when combined with the results of this analysis it raises concerns about the safety of this medication. The current analysis should be considered hypothesis generating and clonidine should be further investigated before it is systematically used for management of PAD.