The present study was designed to investigate the effects of 6 % hes. This randomized study compared the effects on intravascular volume and coagulation of approximate 2000 ml of two isooncotic artificial colloids. The artificial colloid, hydroxyethyl starch hes, is recommended for intravascular volume expansion and colloidosmotic pressure enhancement in dogs and cats. Following intravenous administration of 500 ml 6 % hydroxyethyl starch 0. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. Pdf balanced 10% hydroxyethyl starch compared with balanced. Comparison of hydroxyethyl starch regulatory summaries from. Comparison of hydroxyethyl starch regulatory summaries. Comparison of the effects of albumin 5%, hydroxyethyl. Medical records of all patients presenting between may. Hydroxyethyl starch for fluid replacement therapy in high. A 6 % concentration is commonly preferred with kd and 0. Hemodynamic effects of hypertonic hydroxyethyl starch 6% solution and isotonic hydroxyethyl starch 6% solution after declamping during abdominal aortic aneurysm repair. This randomized clinical trial assesses the effect of hydroxyethyl starch 0.
Effects of 6% hydroxyethyl starch and 3% modified fluid. Mar 27, 2015 objective to determine whether the perioperative use of hydroxyethyl starch 6 % and albumin 5% in elective joint arthroplasties are associated with an increased risk for perioperative complications. Voluven hydroxyethyl starch in sodium chloride injection. Several clinical studies have shown that hydroxyethyl starch hes may be as effective and safe as, but less expensive than, albumin when used for perioperative plasma volume replacement pvr in children. A wellknown side effect of hes solutions in humans and dogs is coagulopathy. An overview of events in hes usage between 2010 to present day is shown in table 1. Objectiveto determine the effect of hydroxyethyl starch hes on colloid oncotic pressure. This article is from yonsei medical journal, volume 55.
Any component of the pump participates in occurrence of these adverse events, one of which is the type of prime solution. However, in critically ill patients, hes is associated with acute kidney injury. Hydroxyethyl starch in cabg the annals of thoracic surgery. Hydroxyethyl starch multiple sizes available sigmaaldrich.
We investigated the safety and efficacy of administering hydroxyethyl starch 6 % 0. Effect of hydroxyethyl starch vs saline for volume. In 45 patients undergoing cardiac surgery, 6 % hydroxyethyl starch 2000. Impact of perioperative administration of 6 % hydroxyethyl. Subgroup analysis of a prospective randomized trial. Comparing the effects of 5% albumin and 6 % hydroxyethyl starch 0. Because different hes preparations have different safety profiles, we sought to determine whether 6 % thirdgeneration hes 0. There were 77 male patients in crystalloid group and 74 in hes group. The sample size calculation was made using pass version 11.
Low molecular weight hydroxyethyl starch 6% compared to albumin. In the perioperative period, artificial colloids are most often infused in doses of 500 ml intravenously. Comparison of 6 % hydroxyethyl starch and 5 % albumin for. Hetastarch is a synthetic, nonionic hydroxyethyl derivative of starch used as a plasma expander when prepared in an isotonic solution. Hydroxyethyl starch medium mw, european pharmacopoeia ep reference standard. Increased vascular permeability is a pathophysiological hallmark of sepsis and results in increased transcapillary leakage of plasma fluid, hypovolemia, and interstitial edema formation. Fulltext pdf ema recommendation to suspend hes is hazardous fulltext. The objective of this trial was to evaluate the influences of albumin 5% and balanced hydroxyethyl starch 6 % 0. Hes is a general term and can be subclassified according to average molecular weight, molar substitution, concentration, c2. Find information on hydroxyethyl starch use, treatment, drug class and molecular formula. Mar 17, 2015 six percent hydroxyethyl starch hes 0. Dec 23, 2019 a safety profile of 6 % hydroxyethyl starch 0.
We aimed to evaluate the effect of hes on perioperative cystatin c cystcderived estimated glomerular filtration rates egfrcystc in patients undergoing open and robotassisted radical prostatectomy. Hydroxyethyl starch is a nonionic starch derivative. Hydroxyethyl starch hes solutions like voluven, hespan or hextend 6% solution are widely used for the treatment of hypovolemia low blood volume when. Hes, hydroxyethyl starch, tetrastarch, and hetastarch, plus specific product names. Albrecht1, judith howard2, alan kovacevic3 and katja n. Hydroxyethyl starch solutions and patient harm the lancet. Oct 25, 2018 use of hydroxyethyl starch hes has come under scrutiny as accumulating evidence has suggested that hes fluids are associated with an increased risk of acute kidney injury and death among the critically ill. Pdf a novel hydroxyethyl starch voluven for effective.
It is categorized based on its in vitro molecular weight. Infusion of 5% human albumin ha and 6 % hydroxyethyl starch 0. Methods presented data derive from an exploratory subgroup analysis of a prospective randomized, singleblinded trial comparing albumin 5% versus balanced hydroxyethyl starch 6 % 0. However, ha and hes may affect blood coagulation and could contribute to increased transfusion requirements. A comparison of the effects of a 4% modified fluid gelatin and a 6 % hydroxyethyl starch on haemodilution, colloid osmotic pressure, haemostasis and renal parameters in healthy ponies z. Several investigators have stated that the use of different resuscitation regimens may have an impact on the development of ali after hemorrhagic shock, by affecting endothelial permeability and capillary leakage. Balanced 10% hydroxyethyl starch compared with balanced 6 % hydroxyethyl starch and balanced crystalloid using a goaldirected hemodynamic algorithm in pancreatic surgery. Jan 08, 2015 following intravenous administration of 500 ml 6 % hydroxyethyl starch 0. Hydroxyethyl starch heshaes, sold under the brand name voluven among others, is a nonionic starch derivative, used as a volume expander in intravenous therapy. Hydroxyethyl starch hes utilization before and after a. Upon intravenous administration, hydroxyethyl starch colloid increases blood volume and thus improves circulation.
The subjects of this study were 262 patients, scheduled to undergo thoracic esophagectomy for esophageal cancer, who were assigned to. In their correspondence in the lancet, ian roberts and colleagues feb 12, p 7361 ask the director general of who to ban the use of hydroxyethyl starch hes solutions worldwide to protect patients. Prolonged duration of cardiopulmonary bypass aggravates the degree of inflammation and. Low molecular weight hydroxyethyl starch 6% compared to albumin 4% during intentional hemodilution. No differences in renal function between balanced 6%. The purpose of our study was to evaluate the effect of 6 % hes 0. Earlier reports suggested that hydroxyethyl starch 0. Effects of 6% hydroxyethyl starch and 3% modified fluid gela.
Comparison of hydroxyethyl starch regulatory summaries from the. Dailymed hydroxyethyl starch in sodium chloride injection. The subjects of this study were 262 patients, scheduled to undergo thoracic esophagectomy for esophageal cancer, who were. Source information for this summary was retrieved from the fda and ema websites 5, 6 using the following general search terms. A study with 10% radiolabeled 14 chydroxyethyl starch 0. Hydroxyethyl starch versus albumin for colloid infusion following cardiopulmonary bypass in patients undergoing. In this large propensitymatched analysis, we aimed to assess the efficacy and safety of replacing ha with hes for intraoperative volume therapy in children undergoing cardiac surgery with cardiopulmonary bypass cpb. The artificial colloid, hydroxyethyl starch hes, is recommended for intravascular volume expansion. Comparison of the effect of albumin 5%, hydroxyethyl starch 0. To determine whether fluid resuscitation of acutely ill adults with 6 % hydroxyethyl starch 6 % hes with a molecular weight of. Comparison of the effects of albumin 5%, hydroxyethyl starch 0. The study was a twocenter, randomized, controlled, parallelgroup, doubleblind trial performed in children aged 212 yr undergoing elective surgery for congenital heart disease under extracorporeal circulation. Average of 1 oh group per 10 glucose units converted to och 2 ch 2 oh. This randomized clinical trial was performed on 50 patients undergoing surgery, aged 2060, with physical status of asa i, ii.
This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. We are conducting a singlecenter, openlabel, randomized, comparative trial with two parallel patient groups to compare human albumin 5 % test drug with hydroxyethyl starch 6. Hydroxyethyl starch hes solutions have had a turbulent history as resuscitation fluids. Hydroxyethyl starch in sodium chloride fda prescribing. Randomised trials of 6% tetrastarch hydroxyethyl starch 0. Hydroxyethyl starch an overview sciencedirect topics. The aim of the current study was to compare the effects of normal saline solution and 6 % hydroxyethyl starch heshaes solution on hemodynamic changes after spinal anesthesia in patients undergoing lower limb orthopedic surgery. The effects of 6% hydroxyethyl starch compared with normal. The use of hes on critically ill patients is associated with an increased risk of death and kidney problems.
Hemodynamic indices were remeasured after the completion of infusion, and then spinal anesthesia was performed. Increased risk in septic shock patients with 10% hes 2000. We are conducting a singlecenter, openlabel, randomized, comparative trial with two parallel patient groups to compare human albumin 5 % test drug with hydroxyethyl starch 6 % 0. Ragaller m1, muller m, bleyl ju, strecker a, segiet tw, ellinger k, albrecht dm. Since the advent of cardiopulmonary bypass, many efforts have been made to avoid the complications related with it. Comparison of the effects of albumin 5%, hydroxyethyl starch. Use of hydroxyethyl starch hes has come under scrutiny as accumulating evidence has suggested that hes fluids are associated with an increased risk of acute kidney injury and death among the critically ill. Pdf fluid resuscitation with 6 % hydroxyethyl starch 0.
In this large propensitymatched analysis, we aimed to assess the efficacy and safety of replacing ha with hes for intraoperative volume therapy in children undergoing cardiac surgery with cardiopulmonary bypass. Then, the patients were randomly divided into two groups and for the control group, 7 mlkg 9% or normal saline and for the experimental group 6 % hydroxyethyl starch were administered. To assess the impact of 6% tetrastarch hydroxyethyl starch hes 0. Pdf balanced 10% hydroxyethyl starch compared with. This agent is almost exclusively excreted by the kidneys and is potentially nephrotoxic. In this study, we aimed to compare the effects of 6 % hydroxyethyl starch 0. Lists the various brand names available for medicines containing hydroxyethyl starch. However, hesassociated coagulopathy has thus far not been investigated in cats. Setting data from 510 different hospitals across the united states participating in the premier. Hemodynamic effects of hypertonic hydroxyethyl starch 6%. Wed like to understand how you use our websites in order to improve them.
Hydroxyethyl substitution of hydroxyethyl starch hes glucose subunits takes place preferentially at the c6and c2positions. Hydroxyethyl starch hes is used for repletion of acute intravasal volume loss in surgical patients. Feb 14, 2018 a study with 10% radiolabeled 14 chydroxyethyl starch 0. The use of artificial colloids has declined in critical care, whereas they are still used in perioperative medicine.
In 20, warnings from both agencies advised against use of hes in critically ill patients, including patients with sepsis, when several large randomized controlled. Do not use hes products, including voluven, in patients. Therefore, we performed an european multicentric prospective observational postauthorization safety study pass to evaluate the use of hes 0. The data on hydroxyethyl starch in noncritically ill patients are insufficient to support perioperative use. Setting data from 510 different hospitals across the united states participating in the premier perspective database. Little is known about the nephrotoxic potential in noncritically ill patients during routine surgery. Hetastarch 6% has an average molecular weight of 200 kda. Several clarifications and corrections are needed to place the authors arguments into proper perspective. Hydroxyethyl starch versus albumin for colloid infusion following cardiopulmonary bypass in patients undergoing myocardial revascularization. Several studies of critically ill patients reported that fluid resuscitation with hydroxyethyl starch hes solutions damages the kidneys, but their use for surgical patients is debated. Objective to determine whether the perioperative use of hydroxyethyl starch 6 % and albumin 5% in elective joint arthroplasties are associated with an increased risk for perioperative complications. The hydroxyethyl starch preparations include tetrastarch, hetastarch, and pentastarch.