Voluven Group Research Articles

Ringer Lactate Versus Voluven In Sepsis In Intensive Care Unit Patients

Abstract Background Sepsis, a syndrome of physiologic, pathologic, and biochemical abnormalities induced by infection, is a major public health concern. Sepsis should be defined as life-threatening organ dysfunction caused by a dys-regulated host response to infection. For clinical operationalization, organ dysfunction can be represented by an increase in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score of 2 points or more, which is associated with an in-hospital mortality greater than 10%. Objective To compare between ringer lactate and voluven in resuscitation of patient with sever sepsis in intensive care unit. Patients and Methods It is a prospective analytical study to compare ringer lactate versus voluven in resuscitation in sever sepsis. The required sample size has been estimated to be 30 patients for each group. A total number of 60 patients were treated for severe sepsis in our ICU during the study period. 30 patients assigned to ringer lactate and 30 patients assigned to HES 130/0.42, there was 40% of patients known to have HTN and 66.7% know to have DM. Results In comparison between the studied groups regarding the ABG data in first day, we found a PH improvement in Voluven group more than Ringer lactate group by P-value 0.020. Pao2 was worsened in Voluven group than Ringer lactate group by p-value 0.022. The laboratory data showed no specific significance between the two groups and C-Reactive protein results were not in the two study groups. Conclusion There’s no significant difference in Patients with severe sepsis assigned to fluid resuscitation with Voluven compared to those receiving Ringer’s lactate in SOFA score results as well as mortality index.

The Rate and Severity of Headache after Caesarean Section under Spinal Anaesthesia are decreased by Hypertonic Solutions: A Randomized Placebo-Controlled Clinical Trial

Aim: To determine the frequency and severity of post-dural puncture headache (PDPH) in women undergoing spinal anaesthesia for caesarean section who received an infusion of Voluven or Ringer before the procedure. Methods: We enrolled 240 full term women scheduled for elective caesarean section in this study. Participants were randomly allocated equally to Ringer (A) and Voluven (B) groups. After arrival in the operating room 500 ml of ringer solution was infused within 10-15 min before spinal block in the Ringer group, but in the Voluven group 500 ml of 6% Hydroxyethyl starch solution was infused to the patients. The frequency and severity of headache were compared between two groups. Results: The frequency of PDPH was higher in patients in Ringer group compared to Voluven group at first day (P=0.01), but there were no significant differences between two groups in second (p=0.23) and third days (p=0.30). The severity of headache in Ringer group was significantly more than patients in Voluven group in every three days significantly. Hypotension occurred in 95 patients in Ringer Group (79.17%) and in 76 patients in Voluven Group (%63.33) (P=0.007). The frequency of nausea and vomiting was seen in 27 patients in Ringer group (22.5%) vs. in 18 patients in Voluven group (15%) (p=0.10). Conclusion: Hydration with hypertonic solutions (Voluven) before caesarean section under spinal anaesthesia can decrease the rate and severity of PDPH compared with hydration with Ringer solution.

The intraoperative therapeutic equivalence of balanced vs saline-based 6% hydroxyethyl starch 130/0.4 and their influence on perioperative acid-base status and renal functions

Study objectiveThis study was designed to evaluate the therapeutic equivalence of balanced 6% hydroxyethyl starch (HES) 130/0.4 (Tetraspan) vs saline-based 6% HES 130/0.4 (Voluven) regarding the volume effect and the effect on acid-base status and renal functions in patients undergoing major urologic procedures. DesignRandomized comparative trial. SettingOperating room and ward. PatientsForty patients, American Society of Anesthesiologists statuses 1 and 2. InterventionPatients were randomly allocated to receive either Voluven (n = 20) or Tetraspan (n = 20). MeasurementsHemodynamic variables. Laboratory variables in the form of arterial blood gases, serum chloride and sodium levels, hemoglobin level, international normalized ratio, and kidney and liver functions were measured after induction of anesthesia (T1), at the end of surgery (T2), and on the first postoperative day (T3). Main resultsBoth groups were comparable regarding the total amount of study drugs and crystalloid consumption. No significant difference in hemoglobin levels between both groups, but there were significant differences between T1 and T2 hemoglobin within both groups and T3 hemoglobin in the Tetraspan group. Both groups were comparable regarding the renal functions, but there was a significant difference between T1 and T2 creatinine within both groups. No significant differences between both groups in liver functions and coagulation profile, but there were significant differences between values at T1, T2 and T3 within each group. Relative to baseline, both pH and bicarbonate decrease significantly in both groups. In the Voluven group, bicarbonate decreased significantly at the end of surgery relative to the Tetraspan group. Serum electrolytes did not vary between both groups. ConclusionBoth balanced 6% HES 130/0.4 (Tetraspan) and saline-based 6% HES 130/0.4 (Voluven) were equally effective for hemodynamic stabilization of patients undergoing major urologic procedures without any significant impact on acid-base status or renal functions.

Joint effects of hydroxyethyl starch and furosemide on acute lung injury induced by paraquat in swine

Objective To discuss the jointly therapeutic effects of 6% hydroxyethyl starch 130/ 0.4 (voluven) and furosemide on acute lung injury induced by paraquat (PQ) in swine. Methods The ALI/ARDS models were established with 20% PQ (20 mL) intraperitoneal injection in 18 healthy female piglets and randomly divided into three groups: voluven group (A) , furosemide group (B) and voluven +furosemide group (C) (n=6 in each group). The heart rate (HR) , mean arterial pressure (MAP) , extravascular lung water index (ELWI) , pulmonary vascular permeability index (PVPI) , partial pressure of carbon dioxide (PaCO2) and oxygenation index (PaO2/FiO2) among the three groups were carefully measured by PICCO (pulse indicator continuous cardiac output) before modeling (baseline) , just after modeling (t0) , and 2 h (t2) , 4 h (t4) , 6 h (t6) and 8 h (t8) after trearment. Needle biopsies of lung tissue were made before modeling and at t0 and t8 and prepared for microscopy observation after Hematoxylin- eosin staining method (HE staning). Repeated measurement data were compared among repeated measures by the ANOVA and the difference between groups was compared by one-wey ANOVA. Results (1) The HR and MAP of all animals increased obviously while the oxygenation index declined significantly at modeling just made (t0) compared to those before modeling (all P 0.05). (2) The ELWI and PVPI of all animals increased obviously at modeling just made (t0) compared to those before modeling (all P <0.05). The ELWI and PVPI were decreased after treatment. And at the same time, the ELWI and PVPI of A and B groups were significantly lower than those of C group after treatment (all P <0.05). (3) The alveolar tissue showed obviously injured changes at modeling just made (t0). The injury was relieved 8h after trearment, which was most markedly in group C. Conclusions With the combination of 6% hydroxyethyl starch 130/ 0.4 and furosemide administered, the acute lung injury induced by paraquat poisoning can be effectively relieved, promoting gas exchange, and improve oxygenation. Key words: Paraquat; Acute lung injury; 6% hydroxyethyl starch 130/ 0.4; Furosemide; Pulse indicates continuous cardiac output monitoring; Extravascular lung water index; Pulmonary vascular permeability index; Oxygenation index

The effect of 6% hydroxyethyl starch 130/0.4 on hemodynamic efficacy and hemostasis in major orthopedic surgery: a comparison with 6% hydroxyethyl starch 200/0.5

Background Clinical trial on patients undergoing major orthopedic surgeries to assess the safety and efficacy of 6% hydroxyethyl starch (HES) 130/0.4 (voluven) in comparison with 6% HES (200/0.5). Patients and methods A total of 40 patients scheduled for major orthopedic surgery were randomized to receive either 6% HES 130/0.4 (voluven group) or 6% HES 200/0.5 (haesteril group) during the intraoperative period. Amount of given colloids and crystalloids, blood loss, and the number of patients who needed blood transfusion were recorded. Mean blood pressure and heart rate were recorded at four time points during the operation. Laboratory measurements included hemoglobin, platelet count, prothrombin time, activated partial thromboplastin time, fibrinogen, and factor VIII concentrations. They were recorded before the surgery (baseline) and at 6 and 24 h after the surgery. Results Mean blood pressure and heart rate were comparable between both groups. There was equivalence of mean infused volumes of voluven and haesteril during the study period ( P = 0.086). The intraoperative blood loss was significantly lower in the voluven group than in the haesteril group ( P = 0.001), and a smaller number of patients in the voluven group required blood transfusion compared with the haesteril group ( P = 0.023). Hemoglobin and platelets decreased significantly at 6 and 24 h after surgery compared with the baseline values, with insignificant difference between both groups. Prothrombin time increased significantly at 6 and 24 h after surgery in both the groups. The increase was significantly more in the haesteril group. Activated partial thromboplastin time increased significantly in the haesteril group at 6 and 24 h after surgery, whereas there was a nonsignificant change in the voluven group. Factor VIII concentration showed a significantly larger increase at 6 and 24 h after surgery in the voluven group than in the haesteril group. Conclusion In surgeries with major blood loss, voluven has a comparable efficacy to haesteril and may reduce coagulation impairment, possibly leading to less requirements of allogenic blood transfusion.

Comparison of the effects of colloid preload, vasopressor administration and leg compression on hemodynamic changes during spinal anesthesia for lumbar disc surgery in knee-chest position.

Background:Hypotension is a serious and the most common adverse effect of spinal anesthesia. Many studies have focused on prevention of hypotension due to spinal anesthesia. The aim of this study was to compare the efficacy of three different methods of using colloid, ephedrine and wrapping of extremities on the incidence of hypotension and bradycardia following spinal anesthesia in patients undergoing elective lumbar disc surgery in knee–chest position.Materials and Methods:A total of 180, ASA (I–II), adult patients candidate of lumbar disc surgery in one or two levels who met the inclusion criteria were randomly allocated in one of three treatment groups of receiving Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection), ephedrine and leg wrapping. After establishment of spinal anesthesia, patients were outsourced and knee–chest position was done. Heart rate and blood pressure of patients were recorded at different times till 60 min after spinal injection. Statistical analyses of data were performed with SPSS (version 20) and by considering groups, values of P < 0.05 were considered statistically significant.Results:Mean systolic blood pressure (119.5 ± 7.4 mmHg) and mean heart rate (71.7 ± 6.7 b/min) were higher in a group receiving Voluven (P < 0.05). The Voluven group significantly experienced less nausea and vomiting in recovery room in comparing with other groups (P = 0.027). They also received significantly less ephedrine (P = 0.012) and ondansetron [12 (20%)] (P = 0.02). Furthermore, patients receiving elastic bandage had significantly more blood loss than the other groups (P = 0.013).Conclusion:Colloid therapy was the most effective method in keeping hemodynamic stability, prevention of decrease in systolic blood pressure and incidence of side effects during spinal anesthesia for lumbar disc surgery in knee–chest position.

A clinical study of VOLUVEN and HES used for acute hypervolemic hemodilution on Hepatectomy

Objective To explore the safety and feasibility of VOLUVEN and HES used for acute hypervolemic hemodilution on selective Hepatectomy. Methods 42 patients （ASA Ⅰ - Ⅱ ） were randomized to the two groups （ Ⅰ , VOLUVEN group; Ⅱ , HES group） ,20 minutes before the operation, the two groups of patients underwent AHH with VOLUVEN and HES respectively at the same quantity and speed, and then the changes of haemodynamics, blood gas analysis,electrolyte and coagulation indexes were detected. Results In I group,the changes of HB,HCT, PLT,central venous pressure had statistical significance before and after AHH（ t = 7. 880,32. 257,7. 303,22. 812, all P = 0.000）. In Ⅱ group,the changes of HB, HCT, PLT, central venous pressure had statistical significance before and after AHH （ t = 5. 398,14.924,11. 171,5. 620, all P = 0. 000）. For inter-group, VOLUVEN has less effect than HES on central venous pressure （t = 2. 367,P = 0： 023）. Conclusion Using VOLUVEN or HES can keep hemodynamics stable and improve the ischemic tolerance for AHH in liver surgery. VOLUVEN has less effect on central venous pressure Key words: Hemodilution; Blood substitutes

Effect of hydroxyethyl starch on tissue perfusion and serum TNF-α、IL-6、IL-8 levels in patients with severe acute pancreatitis

Objective To observe effects of hydroxyethyl starch(130/0.4,voluven)on tissue perfusion and serum TNF-α,IL-6,IL-8 levels in patients with severe acute pancreatitis(SAP).Methods 60 SAP patients with non-operative treatment were randomly divided into voluven group and Ringer's solution group(n =30 per group).In addition to conventional drugs and treatment,of which voluven group daily 15ml/kg intravenously for 5 d;Ringer's solution group daily 20ml/kg intravenously for 5d.Hemodynamic parameters and tissue perfusion indicators were monitored,TN F-α,IL-6,IL-8 levels were examined after treatment 0,12,24,48,96 hours.Results Compared with Ringer solution group,Voluven group therapy high efficiency,faster raise MAP,ScvO2,Phi value,lower HR,Hct(t =2.785,3.126,4.132,3.168,2.218,all P ＜ 0.05).TNFα,IL-6 after 48h treatment,IL-8 after 96h treatment,both groups were significantly decreased,but the voluven group was significantly lower than Ringer's solution group(P ＜ 0.05).Conclusion Voluven could effectively and quickly maintain hemodynamic stability,improve the hemorheological and tissue perfusion,could be more conducive to improving the pancreatic microcirculation,thus inhibiting inflammatory cytokines TNF-α,IL-6,IL-8 release,and had favorable treatment effect on patients with SAP. Key words: Pancreatitis; Hydroxyethyl starch; Tumor necrosis factor-alpha; Interleukin-6; Interleukin-8

Effects of acute hypervolumic hemodilution with 6％ hydroxyethyl starch (130/0.4) on glycometabolism in patients with posterior lumbar decompression and bone graft fixation

Objective To investigate the effects of acute hypervolumic hemodilution (AHH) with 6％ hydroxyethyl starch (130/0.4) on glycometabolism in patients with posterior lumbar decompression and bone graft-fixation. Methods Sixty ASA Ⅰ -Ⅱ selective surgery patients were randomly divided into three groups(n=20): control group (group A), Ringer's solution group (group B) and voluven group (group C). In group B and C, 15 ml/kg Ringer's solution or voluven were infused respectively in 20 min-30 min after induction of anesthesia. The hemodynamics were continuously monitored in three groups. Blood samples were taken and the level of Hb, Hct, glucose(glu), cortisol(cor), glucagon(gln) and insulin(ins) were examined at different time points: prior to the AHH (T1), AHH finished immediately (T2), after surgery (T3), and 2 h after surgery (T4). Also the HOMA-insulin resistance index (HOMA-IRI) and insulin sensitivity index(ISI) were calculated. Results The hemodynamics of B and C groups remained stable at T2 compared with that at T1, but the level of glu, cor, gln and ins declined. At T3 and T4 in group A and B Hb, Hct and ISI significantly decreased(P＜0.05). Glu(11.6±2.3) mmol/L, ins(11.2±2.5) mIU/L, cor(347±39) μg/L, gln (230±19) ng/L and IRI increased markedly (P＜0.05). There were significant changes of glu, cor, gln, ins, IRI and ISI at T1. At T3 and T4 in group C, glu (8.0±2.0) mmol/L, ins (8.5±2.3) mIU/L, cot (282±21) μg/L, gln (197±28) ng/L and IRI elevated to a less degree than that observed in group A and B (P＜0.05). ISI decreased slightly in group C at post operation compared with that in other two groups (P＜0.05). Conclusion Implemented AHH with voluven before surgery can reduce posterior lumbar decompression and bone graft in patients with the concentration of stress hyperglycemia, cortisol, glucagon and insulin resistance. Key words: 6％ hydroxyethly starch; Hemodilution; Blood glucose; Glycometabolism

Effects of infusion of different fluids during controlled hypotension on gastric intramucosal pH and postoperative gastroenterological function

The present study was aimed to investigate the effects of infusion of different fluids combined with controlled hypotension on gastric intramucosal pH (pHi) and postoperative gastrointestinal function in patients undergoing hepatocarcinoma surgery. Forty-five patients (ASA II) scheduled for surgical resection of hepatocarcinoma undergoing controlled hypotension were randomly assigned to three groups and received infusion of 20 mL/kg Ringer's solution (R group), 6% HAES(H group) or 6% Voluven group (W group). Intragastric PgCO 2, pHi, hematocrit and hemoglobin were measured. The significant decrease of pHi and increase of PgCO 2 were produced at 1 and 2 h after controlled hypotension in the R group ( P < 0.05 or P < 0.01). The time of bowel movement after operation was shorter in the W group than the R group. Meanwhile, we also did not find obvious difference in blood gas indexes among the three groups. The infusion of HAES and Voluven during controlled hypotension could improve gastrointestinal perfusion and accelerate the recovery of postoperative gastrointestinal function.

647 Comparison of Balanced 6% Hes Solution to Unbalanced 6% Hes Solution in Hypovolemic Critical Ill Children

Goal of the study: The third generation of unbalanced hydrxyethyl starch (HES) (130/04) (Voluven®) shows favorable physicochemical properties and avoids negative effects on coagulation Recently, increasing evidence reported that balanced, plasma-adapted HES preparation (Volulyte®) has advantage over the unbalanced HES solution in chirurgical adult population and avoids hyperchloremic acidosisWe compare the efficacy Volulyte to Voluven in non chirurgical hypovolemic critically ill children. Materials and Methods: Up to 40 ml/kg of the study fluid was infused until stabilization in 20 pediatric patients admitted with circulatory or respiratory failure with shockThe hemodynamic parameters, volume of the study fluid, biological analysis as well as the evolution of the pH, base excess, bicarbonate, chloride and anion gap were analyzed before, after and 24 hours later after administration. Results: After fluid administration and hemodynamic stabilization, no difference in respiratory frequency, ventilatory conditions, kidney, hematological or coagulation values between different treatment groups was observedIn Voluven group (n= 10 patients) however, there was a significantly higher need for treatment volume per kg body weight. The pH, serum base excess, and anion gap were significantly higher in the Volulyte group (n= 10 patients) while the serum chloride remained significantly lower when compared to the Voluven group whereas the serum bicarbonate remained stable. Conclusion: The two study fluid showed no difference in term of hemodynamic, coagulation or kidney functions The Volulyte group showed however, a clear lower serum chloride values as well as less acidosis as indicated by a higher pH and base excess.

Hemostatic and Electrolyte Effects of Hydroxyethyl Starches in Patients Undergoing Posterior Lumbar Interbody Fusion Using Pedicle Screws and Cages

Prospective, randomized, double blind, clinical study. To compare the hemostatic and electrolyte effects of 2 commonly administered hydroxyethyl starches (HES) in patients undergoing posterior lumbar interbody fusion (PLIF). HES are commonly administered colloid solutions to restore and maintain intravascular volume before transfusion is initiated. However, infusion of HES itself can impair coagulation. HES-induced coagulopathy could be a serious problem in PLIF which involves continuous bone bleeding and oozing. Voluven (Fresenius Kabi, Germany), previously regarded as the least coagulopathic due to its low molecular weight (MW) and degree of substitution (DS), is a saline-based HES. Hextend (Biotime, United States) is a new type of HES with physiologic pH and balanced electrolytes, including calcium, which is beneficial to coagulation. Studies comparing the coagulopathy of Hextend and Voluven are rare. Therefore, coagulation, pH/electrolyte changes, and blood loss using Hextend and Voluven in patients undergoing PLIF were compared. METHODS.: Fifty-four patients scheduled for PLIF involving 3 vertebrae or less were randomly assigned to the Voluven or the Hextend group. Of each solution 15 mL/kg was administered during surgery. Blood loss, coagulation, and electrolyte profiles were checked before infusion and 5 minutes, 3 hours, and 24 hours after the end of infusion. The Hextend group showed slightly better electrolyte balance, however, more coagulation impairment and postoperative transfusion (37% vs. 11%) compared with the Voluven group. The effect of Hextend on coagulation lasted until 24 hours after infusion. If coagulopathy is a concern during PLIF, then, a HES with low MW/DS in a saline-based medium (Voluven) may be a better alternative than a HES with high MW/DS in a balanced salt medium (Hextend).