Intravenous Maintenance Research Articles

Клинико-лабораторные характеристики гриппа у детей с ожирением

Objective. To determine the most general patterns of the clinical and laboratory course of seasonal influenza in children with obesity compared with normal weight children. Patients and methods. A retrospective comparative study of 117 medical records of children with influenza admitted from 2016 to 2019 to the Regional Infectious Diseases Hospital was conducted. The study included two groups of children with seasonal influenza: children with obesity (cases, n = 36) and children with normal weight (controls, n = 81). Nasopharyngeal swabs were tested for influenza and other common respiratory pathogens by PCR. A comparative analysis of structure, prevalence and duration of main clinical symptoms and syndromes, occurrence of influenza complications, data of laboratory general, biochemical and instrumental methods of examination in children with and without obesity was carried out. Results. A prevalence of type A influenza virus (H1N1 sw2009) in all children regardless their body weight status was detected. Children with obesity were admitted to the hospital from out-patient department faster (p < 0.005), duration of their hospitalization were longer (p < 0.005). They had higher frequency of pneumonia (p > 0.05), ketoacidosis (p < 0.001). Intravenous maintenance fluid therapy was ordered more often in patients with obesity (p < 0.03). Hematologic factors of blood in children with obesity were defined by significantly higher level of erythrocyte sedimentation rate (p = 0.0006) and platelet level (p = 0.0032). Conclusion. Obesity is considered as an unfavorable factor which aggravates the course of influenza in children. Higher probability of complications in children with obesity and overweight defines the importance of development of additional approaches to the therapy and prevention of acute respiratory diseases in children. Key words: children, clinical symptoms, influenza, obesity, retrospective study

Anesthetic management of the diaphragmatic pacemaker placement surgery. Our experience in the Institut Guttmann

Abstract Background The diaphragm pacemaker (DP) has proven its utility in replacing mechanical ventilation in patients with chronic spinal cord injury (SCI) and amyotrophic lateral sclerosis (ALS). The DP improves patient quality of life and reduces morbidity and mortality and their associated health care costs. The anesthetic management of these patients and the particularities of the surgical procedure are challenging. The aim of our study is to analyze anaesthetic management and intraoperative complications in patients undergoing DP placement in our hospital. Methods We performed a chart review of patients treated between December 2007 and July 2017, recording the patients' preoperative status, anesthetic management and intraoperative complications. Results The study included 16 patients (5 pediatric) undergoing DP implantation for chronic SCI (63%), ALS (25%) and other neurologic conditions (12%). Abdominal laparoscopy was performed under general anesthesia, with intravenous (87%) or inhalational (13%) induction and maintenance using total intravenous (50%) or balanced (50%) anesthesia. Rocuronium was administered in one case to permit airway management. Complications included: hypotension (50%), difficulties in mechanical ventilation during laparoscopy (31%), pneumothorax (12.5%) and autonomic dysreflexia (6%). Conclusions DP placement under general anaesthesia is a safe intervention in both adult and paediatric patients. Complications derived from both the underlying disease and the surgical technique may appear, and must be rapidly identified and treated to obtain a satisfactory surgical outcome.

Manejo anestésico de la cirugía de implante de marcapasos diafragmático. Experiencia en el Institut Guttmann

BackgroundThe diaphragm pacemaker (DP) has proven its utility in replacing mechanical ventilation in patients with chronic spinal cord injury (SCI) and amyotrophic lateral sclerosis (ALS). The DP improves patient quality of life and reduces morbidity and mortality and their associated health care costs. The anesthetic management of these patients and the particularities of the surgical procedure are challenging. The aim of our study is to analyze anesthetic management and intraoperative complications in patients undergoing DP placement in our hospital. MethodsWe performed a chart review of patients treated between December 2007 and July 2017, recording the patients’ preoperative status, anesthetic management and intraoperative complications. ResultsThe study included 16 patients (5 pediatric) undergoing DP implantation for chronic SCI (63%), ALS (25%) and other neurologic conditions (12%). Abdominal laparoscopy was performed under general anesthesia, with intravenous (87%) or inhalational (13%) induction and maintenance using total intravenous (50%) or balanced (50%) anesthesia. Rocuronium was administered in one case to permit airway management. Complications included: hypotension (50%), difficulties in mechanical ventilation during laparoscopy (31%), pneumothorax (12.5%) and autonomic dysreflexia (6%). ConclusionsDP placement under general anesthesia is a safe intervention in both adult and pediatric patients. Complications derived from both the underlying disease and the surgical technique may appear, and must be rapidly identified and treated to obtain a satisfactory surgical outcome.

Outcome impact of different tranexamic acid regimens in cardiac surgery with cardiopulmonary bypass (OPTIMAL): Rationale, design, and study protocol of a multicenter randomized controlled trial

Tranexamic acid (TxA) reduces perioperative blood transfusion in cardiac surgery; however, the optimal dose of TxA remains unknown. METHODS AND RESULTS: This large-scale, double-blind, randomized controlled trial with a 1-year follow-up enrolls patients undergoing elective cardiac surgery with cardiopulmonary bypass. Patients are randomly assigned 1:1 into either the high-dose TxA group (intravenous bolus [30 mg/kg] after anesthesia followed by intravenous maintenance [16 mg/kg/h] throughout the operation, and a pump prime dose of 2 mg/kg) or the low-dose TxA group (intravenous bolus and maintenance are 10 mg/kg and 2 mg/kg/h, respectively, and a pump prime dose of 1 mg/kg). The primary efficacy end point is the rate of perioperative allogeneic red blood cell (RBC) transfusion defined as the number (%) of patients who will receive at least 1 RBC unit from operation day to discharge. The primary safety end point is the 30-day rate of the composite of perioperative seizures, renal dysfunction, myocardial infarction, ischemic stroke, deep vein thrombosis, pulmonary embolism, and all-cause mortality. The secondary end points are perioperative allogeneic RBC transfusion volume, the non-RBC blood transfusion rate, postoperative bleeding, reoperation rate, mechanical ventilation duration, intensive care unit stay, hospital length of stay, total hospitalization cost, each component of composite primary safety end point, and the 6-month/1-year follow-up mortality and morbidity. We estimated a sample size of 3,008 participants. CONCLUSIONS: The study is designed to identify a TxA dose with maximal efficacy and minimal complications. We hypothesize that the high dose has superior efficacy and noninferior safety to the low dose.

991TiP - PULSE: A single arm trial assessing the activity and safety of avelumab immunotherapy maintenance among patients with locally advanced or metastatic squamous cell penile carcinoma (mSCPC)

BackgroundmSCPC is an orphan disease with a poor prognosis. First line systemic treatment relies on platinum-based polychemotherapies (PBPC). These combinations remain poorly effective with median progression-free survival (PFS) and overall survival (OS) around 7.5 months and 16 months respectively [Pagliaro 2010; Nicholson 2013]. SCPC is a disease with a virally induced oncogenesis, moreover PD-L1 is commonly expressed with an expression rate of 62.2% in primary tumours and a strong correlation between PD-L1 in the primary tumour and metastases [Udager 2016]. Immunotherapies targeting the PD-1/PD-L1 axis are effective in other squamous cell or HPV related cancers. There is no consensus on a second line systemic treatment in mSCPC. Tumour mass is assumed to be reduced as a result of the first line chemotherapy. PBPC are known to be able to trigger immunogenic cell death. The maintenance strategy after systemic chemotherapy which has controlled the disease is a validated concept in many tumour models. Maintenance treatment with immunotherapy after initial PBPC may help to maintain disease control in mSCPC setting. Trial designPULSE trial is a prospective multicenter open label phase II study that will enroll 32 patients. Patients with unresectable locally advanced or metastatic SCPC must have carried out a radiological assessment showing a non-progressive disease after 3 to 6 cycles of a first line PBPC. Patients previously treated by an immunotherapy are excluded. A minimal period of 3 weeks washout after chemotherapy is required before starting intravenous maintenance Avelumab. It will be administered every two weeks at the dose of 10mg/kg until progression or unacceptable toxicity. The primary objective is to assess PFS according to RECIST 1.1 criteria. Secondary objectives are overall survival, impact of PL-L1 expression, safety, quality of life. Exploratory endpoints include blood immune-response monitoring, correlation of tumour immune infiltrate and PD-L1 expression on PFS. Screening across ∼15 sites in France is being conducted with first site initiated in February 2019. Clinical trial identificationNCT03774901. Legal entity responsible for the studyThiery-Vuillemin. FundingPfizer. DisclosureN. Gassian: Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: Astellas; Travel / Accommodation / Expenses: Novartis Pharma SAS; Travel / Accommodation / Expenses: Pfizer. G. Mouillet: Travel / Accommodation / Expenses: Sanofi; Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: Merck Serono; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Janssen Cilag; Travel / Accommodation / Expenses: Bristol-Myers Squibb; Travel / Accommodation / Expenses: Astellas Pharma; Travel / Accommodation / Expenses: Pfizer. F. Calcagno: Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: Bayer HealthCare SAS; Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Bristol-Myers Squibb; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Sanofi. A. Thiery-Vuillemin: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche/ Genentech; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy: Astellas Pharma. All other authors have declared no conflicts of interest.

154 compared to 54\xa0mmol per liter of sodium in intravenous maintenance fluid therapy for adult patients undergoing major thoracic surgery (TOPMAST): a single-center randomized controlled double-blind trial

PurposeTo determine the effects of the sodium content of maintenance fluid therapy on cumulative fluid balance and electrolyte disorders.MethodsWe performed a randomized controlled trial of adults undergoing major thoracic surgery, randomly assigned (1:1) to receive maintenance fluids containing 154 mmol/L (Na154) or 54 mmol/L (Na54) of sodium from the start of surgery until their discharge from the ICU, the occurrence of a serious adverse event or the third postoperative day at the latest. Investigators, caregivers and patients were blinded to the treatment. Primary outcome was cumulative fluid balance. Electrolyte disturbances were assessed as secondary endpoints, different adverse events and physiological markers as safety and exploratory endpoints.FindingsWe randomly assigned 70 patients; primary outcome data were available for 33 and 34 patients in the Na54 and Na154 treatment arms, respectively. Estimated cumulative fluid balance at 72 h was 1369 mL (95% CI 601–2137) more positive in the Na154 arm (p < 0.001), despite comparable non-study fluid sources. Hyponatremia < 135 mmol/L was encountered in four patients (11.8%) under Na54 compared to none under Na154 (p = 0.04), but there was no significantly more hyponatremia < 130 mmol/L (1 versus 0; p = 0.31). There was more hyperchloremia > 109 mmol/L under Na154 (24/35 patients, 68.6%) than under Na54 (4/34 patients, 11.8%) (p < 0.001). The treating clinicians discontinued the study due to clinical or radiographic fluid overload in six patients receiving Na154 compared to one patient under Na54 (excess risk 14.2%; 95% CI − 0.2–30.4%, p = 0.05).ConclusionsIn adult surgical patients, sodium-rich maintenance solutions were associated with a more positive cumulative fluid balance and hyperchloremia; hypotonic fluids were associated with mild and asymptomatic hyponatremia.

The duration of fetal antenatal steroid exposure determines the durability of preterm ovine lung maturation

Antenatal corticosteroids (ACS) are the standard of care for maturing the fetal lung and improving outcomes for preterm infants. Antenatal corticosteroid dosing remains nonoptimized, and there is little understanding of how different treatment-to-delivery intervals may affect treatment efficacy. The durability of a lung maturational response is important because the majority of women treated with antenatal corticosteroids do not deliver within the widely accepted 1- to 7-day window of treatment efficacy. We used a sheep model to test the duration of fetal exposures for efficacy at delivery intervals from 1 to 10 days. For infusion studies, ewes with single fetuses were randomized to receive an intravenous bolus and maintenance infusion of betamethasone phosphate to target 1-4 ng/mL fetal plasma betamethasone for 36 hours, with delivery at 2, 4 ,or 7 days posttreatment or sterile saline solution as control. Animals receiving the clinical treatment were randomised to receive either a single injection of 0.25 mg/kg with a 1:1 mixture of betamethasone phosphate+ betamethasone acetate with delivery at either 1 or 7 days posttreatment, or 2 treatments of 0.25 mg/kg betamethasone phosphate+ betamethasone acetate spaced at 24 hours (giving ∼48 hours of fetal steroid exposure) with delivery at 2, 5, 7, or 10 days posttreatment. Negative control animals were treated with saline solution. All lambs were delivered at 121 ± 3 days gestational age and ventilated for 30 minutes to assess lung function. Preterm lambs delivered at 1 or 2 days post-antenatal corticosteroid treatment had significant improvements in lung maturation for both intravenous and single-dose intramuscular treatments. After 2 days, the efficacy of 36-hour betamethasone phosphate infusions was lost. The single dose of 1:1 betamethasone phosphate+ betamethasone acetate also was ineffective at 7 days. In contrast, animals treated with 2 doses had significant improvements in lung maturation at 2, 5, and 7 days, with treatment efficacy reduced by 10 days. In preterm lambs, the durability of antenatal corticosteroids treatment depends on the duration of fetal exposure and is independent of the intravenous or intramuscular maternal route of administration. For acute 24- to 48-hour posttreatment deliveries, a 24-hour fetal antenatal corticosteroids exposure was sufficient for lung maturation. A fetal exposure duration of at least 48 hours was necessary to maintain long-term treatment durability. A single-dose ACS treatment should be sufficient for women delivering within <48 hours of antenatal corticosteroids treatment.

Clinical Pharmacology-Driven Translational Research to Optimize Bedside Therapeutics of Sotalol Therapy.

Oral sotalol, used in adults for sinus rhythm control, is initiated at 80 mg b.i.d. and titrated to a maximum safe dose. The US Food and Drug Administration recommends monitoring the corrected QT interval (QTc) for at least 3 days, until steady‐state exposure of the drug is reached, before patient discharge, which can significantly impact the total cost of treatment. The objectives of this research were to design an accelerated intravenous sotalol loading and maintenance therapy that will reduce the hospital length of stay and to also evaluate the pharmacoeconomic impact in a hospital setting. Pharmacokinetic simulations of sotalol plasma concentrations vs. times profiles were performed to determine the optimal intravenous/oral transition regimen. A cost minimization analysis from the health sector perspective was conducted to assess the cost savings for these proposed accelerated regimens. For a chosen target dose of 120 mg b.i.d., two infusions of 40 mg over 1 hour and 20 mg over 0.5 hour, each followed up by an evaluation of QTc, can be administered followed immediately by the target oral maintenance dose of 120 mg at the end of the second infusion. Consequently, steady‐state exposure and, therefore, steady‐state QTc are obtained on the first day of therapy, facilitating an earlier hospital discharge. Two and 1‐day mean total cost of −$3,123 (95% confidence interval (CI), −$3,640, −$2,607) −$4,820 (95% CI, −$5,352, −$4,288) were observed for this strategy, respectively. We are proposing an intravenous to oral transition strategy for sotalol that has the potential to significantly reduce cost and increase patient convenience.

Isotonic versus Hypotonic Intravenous Maintenance Fluids in Children: A Randomized Controlled Trial.

To compare the incidence of hyponatremia during the first 48h in hospitalized children receiving normal saline vs. N/2 saline as maintenance intravenous fluid. This open label, randomized controlled trial to compare the incidence of hyponatremia in hospitalized children receiving normal saline (0.9% sodium chloride in 5% dextrose) vs. N/2 saline (0.45% sodium chloride in 5% dextrose) as maintenance fluid was conducted from December 2014 through November 2015 in a tertiary care teaching hospital. Children between 1 mo and 18 y requiring maintenance intravenous fluids were randomized to receive normal saline with 5% dextrose (n = 75) or N/2 saline with 5% dextrose (n = 75). Both groups were comparable for demographic variables and illness severity at baseline. Incidence of hyponatremia at 24h of hospitalization was comparable between normal saline and N/2 saline group, 3(4%) vs. 6(8%) cases, respectively; p value 0.494. Mean serum sodium levels were marginally higher in normal saline group (138.3 ± 6.0mEq/L) as compared with N/2 saline group (135.1 ± 4.4mEq/L) (p value <0.01) at 24h of hospitalization. Incidence of hyponatremia at 48h and hypernatremia at 24 and 48h was comparable in two groups. The use of either N/2 saline or normal saline in sick children at standard maintenance fluid rates is associated with low but comparable incidence of hypo or hypernatremia in first 24h of hospitalization. Both types of fluids appear acceptable in hospitalized sick children.

Clinical features and outcomes of patients with myasthenia gravis.

Objectives:Objectives: To report clinical and laboratory features and outcomes of patients with autoimmune myasthenia gravis (MG) recruited from a single center in Saudi Arabia.Methods:We retrospectively reviewed prospectively collected data obtained from MG patients who have undergone examination and follow-up at our neuromuscular clinic between August 1, 2014 and January 31, 2019.Results:Ninety-five patients (55 females) were included. The mean age of onset of MG was 40.5±18.1 years in males and 31.3±15 years in females (p=0.009). The mean duration of follow-up at our clinic was 34.7±14.1 months, while the mean duration since MG onset was 8.0±7.2 years. Of all patients, 92.6% had generalized MG, 82.1% had acetylcholine receptor (AChR) antibodies, 4.2% had muscle-specific tyrosine kinase (MuSK) antibodies, 78.9% had early-onset MG with no second peak after age of 50 years, 22.1% had myasthenia crisis, 12.6% had refractory MG, 31.6% had thymic hyperplasia, 10.5% had thymoma, and 61.1% required ≥2 immunosuppressive therapies. At the last follow-up, 93 patients had achieved an optimal outcome (MG Foundation of America classification ≤ II). No patient with double-seronegative (dSN)-MG had thymoma, needed rituximab or intravenous immunoglobulin maintenance therapy, or was classified as refractory MG.Conclusion:Contrary to other studies, we did not observe a second-peak of MG onset. Clinical outcomes were favorable in the majority of our patients.

Comparative Study Between Total Intravenous Anesthesia Versus Volatile Induction and Maintenance Anesthesia with Sevoflurane for Bariatric Operations

Background: Morbid obesity is defined as a body weight 160% above the ideal weight for survival or 40 kg/m2 or >35 with serious comorbidity. Long-term surveys revealed that surgical intervention has been the only method to effectively sustain weight loss in these patients. Objectives: To compare total intravenous anesthesia applied with propofol-fentanyl to sevoflurane single breath and maintenance anesthesia. Patients and Methods: This prospective randomized clinical study was approved by the ethics committee in AlAzhar University and a written informed patient's consent was obtained. This study included 50 patients of both sexes, admitted for bariatric surgery carried out at Al-Azhar University Hospitals (El-Hussein and Bab El-Sharia). They were randomly allocated into two equal groups, TIVA group: 25 patients will receive total intravenous anesthesia applied with propofol-fentanyl. Group VIMA: sevoflurane single breath induction and maintenance group: 25 patients will receive - sevoflurane single breath induction and maintenance. Results: Total intravenous anesthesia using (fentanyl and propofol). Volatile induction and maintenance anesthesia (Inhalational anesthesia) using (fentanyl and sevoflurane). The following parameters were assessed between the 2 groups: Hemodynamics, SPo2 and ET Co2 were continuously monitored and recorded at 15 min interval. Conclusion: This study showed that both TIVA and VIMA were effective in bariatric surgeries. Regarding neuroendocrine stress response, TIVA group was provided suppressed hormone levels suggesting that there was suppression of stress response unlike VIMA group that showed even raised serum levels of those hormones.

Nurses’ peripheral intravenous catheter-related practices: a descriptive study

Background: Peripheral intravenous catheter (PIVC) insertion and maintenance are the procedures most commonly performed by nurses in clinical settings. However, current catheter failure rates are high, thus compromising the patient’s therapeutic plan and well-being. Objective: To understand nurses’ practices during PIVC insertion and maintenance. Methodology: A transversal and descriptive study was conducted in a cardiology ward in central Portugal. Nurses’ (n = 26) practices during PIVC management were observed and recorded by a research nurse during the morning shift, using a checklist based on transnational standard of care (SoC) recommendations. Results: During PIVC insertion (n = 38) the main digressive areas included glove usage (55.2%), use of the aseptic non-touch technique (44.7%), hand hygiene (18.4%-84.2%), and patient education (28.9%). Regarding PIVC maintenance (n = 66), catheter hub disinfection (78.8%), catheter flushing (53.3%- 78.8%), and patient education (24.2%) were the main deviating areas found. Significant PIVC failure rates were found (25.8%). Conclusion: Overall, a substantial number of PIVC-related practices does not comply with current SoC recommendations, which may pose a risk to patient safety and care quality

Hypotonic and isotonic intravenous maintenance fluids in hospitalised paediatric patients: a randomised controlled trial

ObjectiveTo compare the changes in serum sodium and acid/base status in patients receiving hypotonic and isotonic solutions.DesignA randomised, controlled and double-blind clinical trial.SettingDepartment of Paediatrics in a tertiary general hospital...

E036 Anti-signal recognition peptide myopathy successfully treated with intravenous immunoglobulin and maintenance mycophenolate mofetil

E036 Anti-signal recognition peptide myopathy successfully treated with intravenous immunoglobulin and maintenance mycophenolate mofetil

The impact of intravenous isotonic and hypotonic maintenance fluid on the risk of delirium in adult postoperative patients: retrospective before-after observational study.

To assess the impact of intravenous isotonic and hypotonic maintenance fluid on the risk of delirium in adult postoperative patients, we conducted retrospective before-after study in a tertiary teaching hospital. We examined all adult patients admitted ICU after an elective operation for head and neck cancer, or esophageal cancer from February 2014 to January 2017. From February 2014 to July 2015, patients were administered hypotonic fluid (sodium; 35mmol/L) as the National Institute for Health and Care Excellence (NICE) have recommended. From August 2015 to January 2017, patients were administered isotonic fluid (sodium; 140mmol/L). We defined the incidence of delirium as the primary outcome. The delirium was defined as the Intensive Care Delirium Screening Checklist during the ICU stay ≥ 4. A propensity score-matched model was used to adjust confounders. As postoperative intravenous maintenance fluid, hypotonic fluid was administered to 119 patients and isotonic fluid was administered to 92 patients. Among those total cohorts, the incidence of postoperative delirium in the hypotonic group was 21.8%, which was significantly higher than that (9.8%) in the isotonic group (p = 0.019). After propensity score matching, we selected 77 patients in each group. The incidence of delirium during the ICU stay in the hypotonic group was 26.0%, which was significantly higher than the incidence of 11.7% in the isotonic group (p = 0.023). In this study, the use of postoperative hypotonic maintenance fluid was associated with a higher risk of postoperative delirium than that when isotonic maintenance fluid was used.

Safety of Pediatric Peripheral Blood Stem Cell Harvest in Daycare Setting: An Institutional Experience.

Introduction:Children serving as a donor for their siblings will require anesthesia or sedation. In view of shortage of time and space in operating room setting, peripheral blood stem cell (PBSC) harvest is performed as a daycare procedure.Aim:This study aims to find out whether performing PBSC harvest in hematology blood collection area as a daycare procedure is safe or not.Settings and Design:This secondary analysis included 164 pediatric PBSC harvest (154 pediatric donors, of which 10 had repeat harvesting done) donors, performed under anesthesia, in the Department of Hematology, between January 2009 and June 2017.Materials and Methods:Donors were examined, informed consent was obtained, and adequate premedications were ensured. Induction was intravenous for cooperative donors or inhalational sevoflurane followed by intravenous maintenance infusion using either face mask or a laryngeal mask airway (LMA). During the procedure, vitals are monitored with a noninvasive monitor. Normal hemodynamics were ensured before transferring the children to the ward.Statistical Analysis:Statistical analysis was performed using SPSS 16.0 statistical software. Descriptive statistics and frequencies were used for the data description.Results:A total of 137 donors (median age of 5 years) were induced with sevoflurane and LMA was used in 84 children and face mask in 53. Twenty-seven children cooperated for intravenous induction. Various combinations of propofol, dexmedetomidine, and ketamine were used with respiratory and hemodynamic stability. The median duration of anesthesia was 250 (165–375) min. The recovery from anesthesia was smooth with a median wake-up time of 20 (5–60) min.Conclusion:This retrospective analysis demonstrates that nonoperating room anesthesia for pediatric age group for PBSC harvest can be safely and successfully accomplished outside the operation room setting by a consultant anesthesiologist.

High Vs. Low-Intensity Bridging Chemotherapy in Children with Acute Lymphoblastic Leukemia Awaiting Chimeric Antigen Receptor T-Cell Therapy: A Population-Based Study from Ontario, Canada

Background: Chimeric antigen receptor T-cells (CAR-T) have emerged as a promising treatment for children with relapsed/refractory acute lymphoblastic leukemia (ALL). While CAR-T outcomes have been published, little data exist on how to manage these patients for the weeks to months between T-cell collection and CAR-T infusion. Unlike stem cell transplant (SCT), where higher burden of disease is associated with poor outcomes and is often a contraindication, successful outcomes for children with high disease burden pre-CAR-T have been demonstrated. Thus, traditional high-intensity chemotherapy for relapsed ALL that aims to minimize disease burden but carries significant morbidity may not be the best option for pre-CAR-T populations. We thus compared our population-based experience in using high vs. low-intensity chemotherapy regimens to bridge patients in terms of toxicity, inpatient days, and success in reaching CAR-T infusion.Methods: The Hospital for Sick Children (Sickkids) is the provincial referral centre for cellular therapy for children in Ontario, Canada. All Ontario children referred to Sickkids between 2014-2018 for first T-cell collection with intent to proceed to CAR-T therapy were included and followed until CAR-T infusion, decision to pursue alternative therapy, or death. Bridging regimen details were collected and classified as low vs. high intensity based on whether such therapy was likely associated with >7 days of neutropenia. Disease and outcome variables were compared between high vs. low intensity regimens using Chi squared, Fisher's exact, or Wilcoxon tests.Results: The cohort included 32 patients with a median age of 9.7 years at the time of first T-cell collection [interquartile range (IQR) 6.0-12.3]. The median number of previous relapses was 2 (IQR 1-2), 14 (44.0%) had undergone prior SCT, and 4 (12.5%) had Down syndrome. The vast majority of patients (28, 87.5%) were successfully bridged to receive CAR-T therapy with a median time to infusion of 81 days (IQR 60-105). Two patients experienced manufacturing failure and pursued SCT instead, 1 died of toxicity, and 1 was still awaiting infusion at the end of the study period. Low-intensity bridging regimens were used following collection for 19 (59.4%) patients, most often based on low-dose intravenous methotrexate, 3-drug induction (vincristine/steroids/asparaginase), or maintenance therapy. The most common high-intensity regimens included cyclophosphamide/etoposide, high dose cytarabine, or 4-drug induction (vincristine/steroids/asparaginase/anthracycline). Patients receiving high-intensity therapy did not seem to have more aggressive disease prior to starting bridging treatment (as indicated by peripheral blasts, number of previous relapses, prior SCT) that would have justified choosing high-intensity treatments. Patients receiving initial high-intensity regimens were however more likely to have been collected in first half of the study period (Table 1). Patients receiving initial high-intensity regimens also developed more microbiologically documented infections and experienced a greater number of inpatient days (Table 1). Excluding patients experiencing manufacturing failure or still awaiting CAR-T at the end of the study period, the likelihood of receiving CAR-T also did not vary [high-intensity regimen - 11/12 (91.7%) vs. low-intensity regimen - 17/17 (100%); p=0.41].Conclusions: We demonstrate in our population-based cohort of heavily pre-treated and high-risk patients that initial low-intensity chemotherapy had a very high likelihood of successfully bridging children to CAR-T infusion. Low-intensity bridging regimens were associated with lower rates of toxicity and higher quality of life as indicated by fewer inpatient days. Low-intensity regimens should be considered the first line option in this population. [Display omitted] DisclosuresGrupp:Jazz Pharmaceuticals: Consultancy; Adaptimmune: Consultancy; University of Pennsylvania: Patents & Royalties; Novartis Pharmaceuticals Corporation: Consultancy, Research Funding. Maude:Novartis Pharmaceuticals Corporation: Consultancy, Membership on an entity's Board of Directors or advisory committees.

Can the implementation of a PIVC bundle reduce bloodstream infection? A systematic review

Introduction: A 5-item bundle has been shown to lower central line-associated bloodstream infection (CLABSI) rates in adult intensive care units. However, the impact of peripheral intravenous catheter (PIVC) insertion and maintenance bundles in the general hospital population is unclear.

Hyponatraemia in a Lao paediatric intensive care unit: Prevalence, associations and intravenous fluid use.

Hyponatraemia is a common and potentially deadly complication affecting hospitalised children world-wide. Hypotonic intravenous fluids can be a significant exacerbating factor. Exclusive use of isotonic fluids, coupled with rigorous blood monitoring, has proven effective in reducing hyponatraemia in developed settings. In developing countries, where hyponatraemia is often more common and severe, different factors may contribute to its incidence and detection. We aimed to determine the prevalence and disease associations of hyponatraemia and describe the intravenous maintenance fluid prescribing practices in a Lao paediatric intensive care unit. We conducted a cross-sectional study of 164 children aged 1 month to 15 years admitted to intensive care at a tertiary centre in Lao People's Democratic Republic (PDR) and recorded their serum sodium and clinical data at admission and on two subsequent days. Hyponatraemia was detected in 41% (67/164, confidence interval 34-48%) of children, the majority of which was mild (34%, 56/164) and present at admission (35%, 55/158). Hyponatraemia was more common in malnourished children (odds ratio (OR) 2.3, P = 0.012) and females (OR 1.9, P = 0.045). Hyponatraemia correlated with death or expected death after discharge (OR 2.2, P = 0.015); 88% received maintenance intravenous fluids, with 67% of those receiving a hypotonic solution. Electrolyte testing was only performed in 20% (9/46) of patients outside the study protocol. Hyponatraemia is highly prevalent in critically ill children in Lao PDR, as is the continued use of hypotonic intravenous fluids. With financial and practical barriers to safely detecting and monitoring electrolyte disorders in this setting, this local audit can help promote testing and has already encouraged changes to fluid prescribing.

PSY111 - PHARMACOECONOMIC EVALUATION OF BIOSIMILAR RECOMBINANT ALPHA-EPOETIN IN THE TREATMENT OF ANEMIA IN HEMODIALYSIS PATIENTS

To perform an economic evaluation of biosimilar epoetin alpha (EPO α), originator darbepoietin alpha (DARB) and pegylated epoetin beta – (continuous erythropoietin receptor activator, CERA) in patients on haemodialysis (HD). administration of erythropoiesis stimulating agent (ESAs) is the standard of care for treatment of anemia in hemodialysis patients. a cost-minimization analysis was performed in adult outpatients treated with ESAs for anemia due to CKD. Direct costs of ESA treatment were calculated for one hemodialysis patients. A Decision tree model was developed to compare cost for intravenous maintenance dose (median weight - 75 kg) between the drug arms: biosimilar EPO α 33.3 ME/kg three times-weekly, DARB 0.5 mkg/kg once weekly and CERA 60 mkg every two weeks (Q2W) or 120 mkg per month. Unit costs for drugs: EPO α 2500 ME, DARB 20 and 30 mkg and CERA 50, 75 and 150 mkg vial were estimated from national published sources (exchange rate mean in 2018 - €1 = 71.8 RUB). One-way sensitivity analyses were performed to test model robustness. total annual cost for short-acting biosimilar epoetin alfa was €821, for originator DARB - from €4,559 to €5,556 (for 20 mkg and 30 mkg vial respectively) and for originator CERA treatment - from €1,846-1,999 (for patients not currently treated with an ESA) to €2,269 – €2,917 (for CERA after previous weekly short-acting epoetin alfa with dose >8000 units per week). Therefore, the use of intravenous biosimiliar epoetin alfa could be associated with a cost-saving of 56-85% with the assumption that all ESA have similar effectiveness. The sensitivity analysis showed that the results are stable under a wide range of assumptions. managing hemodialysis patients with biosimilar epoetin alfa is consistently cost saving over treatment with originator epoetin alfa and darbepoetin alfa.