The pharmacy and therapeutics committee removed all hydroxyethyl starch hes products at that time secondary to a june 20, fdaissued medwatch. No differences in renal function between balanced 6%. One liter of 6% solution hespan reduces factor viii level by 50% and will. Hydroxyethyl starch is a form of plant starch that has been partially hydrolyzed to extend the duration of action of the molecule. Hydroxyethyl starch hes solutions like voluven, hespan or hextend 6 % solution are widely used for the treatment of hypovolemia low blood volume when plasma volume expansion is desired. Lists the various brand names available for medicines containing hydroxyethyl starch.
Volulyte contains the active ingredients hydroxyethyl starch. Rahimi et 201 comparing the efficacy of 6% hydroxyethyl. Summaries for consumers hydroxyethyl starch hes versus other fluid therapies. Original article the effects of tranexamic acid and 6%. Molecules smaller than the renal threshold 6070 kda are readily excreted in the urine while a small part of the larger ones are metabolized by plasma. The artificial colloid, hydroxyethyl starch hes, is recommended for intravascular volume expansion. Formulary update redosing of reversal agents in the. Hydroxyethyl starch associated pruritus has been reported in some patients with deposits of hydroxyethyl starch in peripheral nerves.
The two hes solutions were infused 60g as a single dose within 30 minutes in healthy volunteers using a. Postoperative renal replacement therapy after hydroxyethyl. Pdf equal effects of gelatin and hydroxyethyl starch 6%. Information on toxicological effects toxicological effects not regarded as a health hazard under current legislation. Pharmacokinetics of hydroxyethyl starch springerlink. The aim of this study was to investigate whether a recently developed low molecular, low substituted hydroxyethyl starch hes 0. Rcts, 4 of them doubleblind and the others openlabel. Name of corporation mom hydroxyethyl starch fetrastarch inj 6 % 500m1 bottle i br. Acute toxicity oral acute toxicity oral ld mgkg 50,000. Pdf this article aims to highlight the positions of the food and drug administration and the.
Mar 21, 2017 this article aims to highlight the positions of the food and drug administration and the european medicines agency regarding use and marketing of hydroxyethyl starch hes products, and how these have changed over recent years. The effects of 6 % hydroxyethyl starch compared with normal saline on controlling undesirable hemodynamic changes following spinal anesthesia in patients undergoing orthopedic surgery. Hydroxyethyl starch tetrastsrch inj 670 500m1 bottle 201718 datel \ tolnorc name of schem nhm budget jssk delivery period. Hydroxyethyl starch heshaes, sold under the brand name voluven among others, is a. Feb 21, 2020 do not use hydroxyethyl starch hes products, including 6 % hetastarch in 0. Hydroxyethyl starch multiple sizes available sigmaaldrich. A comparison between 25% albumin and 6 % hydroxyethyl starch solutions on lung water accumulation during and immediately after cardiopulmonary bypass. Hydroxyethyl starch70 and hes450 did not differ much from each. Hydroxyethyl starchbased nanoparticles featured with.
Equal effects of gelatin and hydroxyethyl starch 6 % hes 0. Large randomised clinical trials have reported an increased risk of kidney dysfunction and. Hydroxyethyl starch an overview sciencedirect topics. Voluven tetrastarch dosing, indications, interactions. Analysis of the recorded data files was performed by blinding the type of fluid used before evaluation. Hydroxyethyl starch hes is a water soluble semisynthetic polysaccharide that is used as a plasma volume expander and cryoprotectant. The use of hes on critically ill patients is associated with an increased risk of death and kidney problems. A sequential and propensitymatched analysis author links open overlay panel samuel degoul a emmanuel chazard b c antoine lamer c gilles lebuffe a.
Blasco v, leone m, antonini f, geissler a, albanese j, martin c. So for example, one commercially available hydroxyethyl starch voluven is described as 6 % hes 0. In order to produce a fully biodegradable amphiphilic polymer, hes was esterified with lauric, palmitic, and stearic acids under mild reaction conditions using dicyclohexyl carbodiimide dcc and dimethylaminopyridine dmap. A study with 10% radiolabeled 14chydroxyethyl starch 0. What links here related changes upload file special pages permanent. Dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the hemodynamic and hydration status. Hydroxyethyl starch is a synthetic colloid volume expander that is used to maintain vascular volume in animals with circulatory shock. Trials conducted without irb approval by joachim boldt pdf, march 4. Hydroxyethyl starch hes is a derivative of amylopectin, which is a highly branched compound of starch. It appears that the authors conclusions are justified and likely to be reliable. Permoad medical research, veterans administration hospital and university of michigan medical center, ann arbor, michigan 48105 red blood cells can be. If you do not see its contents the file may be temporarily unavailable at the journal website or you do not have a pdf plugin installed and enabled in your browser. Saved albumin was only analyzed in patients receiving more hes 0. Adverse effects of hes on survival and organ function have been reported.
The control group included 160 term neonates with hypoxicischemic encephalopathy undergoing routine intensive care with normal saline at a dose of 20 mlkg as the. Hydroxyethyl starch ietrastarch inj 6 % 500m1 bottle sr. Original article effects of hypertonic saline hydroxyethyl. Hydroxyethyl starch 6 % voluven was designated nonformulary and not available in august 20. Randomized trials of 6 % tetrastarch hydroxyethyl starch 0.
The hydroxyethyl starch preparations include tetrastarch, hetastarch, and pentastarch. Do not use hes products, including voluven, in patients with. Average of 1 oh group per 10 glucose units converted to och 2 ch 2 oh. The volume effect and safety of 6 % hydroxyethyl starch 0. Do not use hes products, including voluven, in patients. In this study, we aimed to compare the effects of 6 % hydroxyethyl starch 0. So we considered it was relatively safe to administer 250 ml bolus dose of 7. Hydroxyethyl starches hes are fluid products that are commonly used in clinical practice, however they have been associated with negative effects on kidney function. Voluven hydroxyethyl starch in sodium chloride injection. Jun 17, 2016 the crystalloid versus hydroxyethyl starch trial chest was an investigatorinitiated, randomisedcontrolled trial that compared resuscitation with 6 % hydroxyethyl starch 04 with 09% sodium chloride saline in 7000 eligible patients in the intensivecare unit icu. Albrecht1, judith howard2, alan kovacevic3 and katja n. Hydroxyethyl starch heshaes, sold under the brand name voluven among others, is a nonionic starch derivative, used as a volume expander in intravenous therapy. Little is known about the nephrotoxic potential in noncritically ill patients during routine surgery.
The authors concluded that the published trials were of poor quality and there was not enough data to reliably estimate the benefits and risks of 6 % hydroxyethyl starch 0. Search results for hydroxyethyl starch at sigmaaldrich. Hydroxyethyl starch is a nonionic starch derivative. Plasma volume expansion by medium molecular weight. The use of artificial colloids has declined in critical care, whereas they are still used in perioperative medicine. Hydroxyethyl starch in balanced electrolyte solution hextend.
The study included 26 neonates weighing 6904030 g gestational age, 2640 wks, without cardiac or renal failure or major hemostasis abnormalities and requiring a. Bioequivalence comparison between hydroxyethyl starch 0. A prospective, randomized, doubleblinded, pilot study. There was a significant decrease in reaction time in the preparations treated with hydroxyethyl starch 6 % and modified fluid gelatin 4%, reflecting activation of initial fibrin formation. Increased risk in septic shock patients with 10% hes 2000. Hydroxyethyl starch use for patients with postpartum. The effects of 6% hydroxyethyl starch compared with normal. Hydroxyethyl starch hes is a natural polysaccharide evolved from amylopectin that has a wide range of applications in human health care such as a blood volume expander, plasma substitute, an antishock component in surgeries and antitumor for different cancer treatments. Hydroxyethyl starch in sodium chloride fda prescribing. In 20, warnings from both agencies advised against use of hes in critically ill patients, including patients with sepsis, when several large randomized controlled.
Plasma volume substitute indicated for treatment and prophylaxis of hypovolemia. Large unit red cell cryopreservation with hydroxyethyl starch e. To investigate effect of equal volumes 250 ml of 7. Ingredients volulyte contains hydroxyethyl starch 0. Changes in regulations on hydroxyethyl starch in the european union. These trials have influenced clinical practice and medical regulatory authorities5, 6 worldwide. This medwatch noted that intravenous hes should not be used in critically ill adults secondary. A 6 % concentration is commonly preferred with kd and 0. A comparison between 25% albumin and 6% hydroxyethyl. However, the efficacy of 6 % hydroxyethyl starch hes 0. Effects of 6% hydroxyethyl starch and 3% modified fluid. Large unit red cell cryopreservation with hydroxyethyl starch. It is a modified branchedchain glucose polymer derived from amylopectin sources such as potatoes, sorghum, or maize.
Supporting documents older than three years 6 % hydroxyethyl starch 0. Get a printable copy pdf file of the complete article 623k, or click on a page image below to browse page by page. A significant increase in clot formation time was noted in the hydroxyethyl starch 6 %. Hydroxyethyl starch trial chest,4 remain the two largest randomised controlled trials rcts ever conducted in intensive care medicine. The volume effect and safety of 6% hydroxyethyl starch. There are limited data on the efficacy of early fluid resuscitation with thirdgeneration hydroxyethyl starch hes in burn injury. Any component of the pump participates in occurrence of these adverse events, one of which is the type of prime solution. Effects of 6 % hydroxyethyl starch and 3% modified fluid gelatin on intravascular volume and coagulation during intraoperative hemodilution mortelmans, yves j.
Hydroxyethyl starch solutions in critically ill or septic patientsupdate 15. Hydroxyethyl starch versus saline for resuscitation of. This openlabel study was designed to investigate the pharmacokinetic and pharmacodynamic profiles of hextend in 21 healthy volunteers. Hydroxyethyl starch has recently become the subject of renewed interest because of the introduction of a new specification, hydroxyethyl starch 0. The objective of this trial was to evaluate the influences of albumin 5% and balanced hydroxyethyl starch 6 % 0. Fda warns of increased mortality risk with hes solution. It is categorized based on its in vitro molecular weight. The elimination depends on molar substitution degree. Influence of different hydroxyethyl starch hes formulations on. Author affiliations are listed at the end of this article. The effects of tranexamic acid and 6% hydroxyethyl starch hes solution 0. Following intravenous administration of 500 ml 6 % hydroxyethyl starch 0.
An uncontrolled, openlabeled, multicenter study 329 reached. In 45 patients undergoing cardiac surgery, 6 % hydroxyethyl starch 2000. Pdf comparison of hydroxyethyl starch regulatory summaries from. Do not use hydroxyethyl starch solution in critically ill patients because of the increased risk for death and renal injury, the agency said today. The number of patients exposed to hes solutions for infusion in the.
Forty asa iii patients scheduled for elective neurosurgi. Dec 19, 2014 hydroxyethyl starch hes products are synthetic colloid solutions used for plasma volume expansion. A study with 10% radiolabeled 14 chydroxyethyl starch 0. Since the advent of cardiopulmonary bypass, many efforts have been made to avoid the complications related with it. Hydroxyethyl starch european medicines agency europa eu. The present study aimed to assess the efficacy and safety of replacing human albumin 5% with 6 % hes 0. Find information on hydroxyethyl starch use, treatment, drug class and molecular formula. Comparison of hydroxyethyl starch regulatory summaries from the. Therapeutic epidural injection of hydroxyethyl starch 20 ml combined with sufentanil 5. The safety and efficacy of a 6% hydroxyethyl starch solution vs. Hydroxyethyl starch 9005270 not listed not listed 6 water for injection 7732185 2317912 not listed additional information. A comparison of a 4% modified fluid gelatin and a 6%.
Postoperative renal replacement therapy after hydroxyethyl starch infusion. Differences in the chemical structure between waxy maize and potato starch based hydroxyethyl starch plasma volume expander. Comparison of hydroxyethyl starch regulatory summaries from. In this randomized, controlled, doubleblind trial, 48 patients with severe burn injury were assigned to receive either lactated ringers solution plus 6 % hes 0. Volulyte 6 % is a clear to slightly opalescent, colourless to slightly yellow solution which comes in a plastic bag. Hydroxyethyl starch hes is a watersoluble polysaccharide derivative and its properties can be tuned by several major parameters such as molecular weight, degree of hydroxyethyl substitution, and the substitution pattern c2c 6 substitution ratio alone or in combination 7. Comparing the efficacy of 6% hydroxyethyl starch 0.
Hydroxyethyl starch in balanced electrolyte solution. A sequential and propensitymatched analysis author links open overlay panel samuel degoul a emmanuel chazard b c antoine lamer c gilles lebuffe a alain duhamel b c benoit tavernier a. Earlier reports suggested that hydroxyethyl starch 0. The crystalloid versus hydroxyethyl starch trial management committee. Caring for the critically ill patient association of. Increased vascular permeability is a pathophysiological hallmark of sepsis and results in increased transcapillary leakage of plasma fluid, hypovolemia, and interstitial edema formation. Proprietary to adjust ph ingredients indicated as hazardous have been assessed under standards for workplace safety. Case report epidural injection of hydroxyethyl starch in the. Early fluid resuscitation with hydroxyethyl starch 0. Hazardous decomposition products hazardous decomposition products no data available. Further prospective studies of epidural injection of hydroxyethyl starch in patients with adp are required to create.
1670 974 376 804 1316 63 816 1300 1042 1567 1425 1416 629 687 446 1447 1320 583 1098 1375 139 1080 757 445 1348 416 1356 1302 764 1371 662 650 1316 90 1144