Hydroxyethyl starch definition of hydroxyethyl starch by. A study with 10% radiolabeled 14chydroxyethyl starch 0. 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. Review of hydroxyethylstarch containing solutions for. Hydroxyethyl starch multiple sizes available sigmaaldrich. Hydroxyethyl starch solutions for infusion european medicines. Hydroxyethyl starch an overview sciencedirect topics. This follows further reflection, in consultation with eu member states, on whether it would be feasible to introduce new measures that would effectively. The hydroxyethyl starch preparations include tetrastarch, hetastarch, and pentastarch. Hydroxyethyl starch use in horses vetlexicon equis from. Colloid therapy for critically ill patients todays.
In daily practice, the assessment of individual thresholds in order to optimize cardiac preload and avoid hypovolemia or deleterious fluid overload remains a challenge. Protein in excess, fat, dietary cholesterol, methionine in meat, poultry, fish, eggs, and cheese, and dietary acid in animal foods are toxic, and starch is the path to detoxification and spontaneous. Hydroxyethyl starch hetastarch is a colloid solution available in the united states as a 6% solution in 0. This book argues that humans are naturally starchivores who thrive on a starchcentered diet.
Hydroxyethyl starch hes comprises of a family of semisynthetic, polydisperse colloid solutions made up of large ethylated, polymerized amylopectin molecules figure 1. Hydroxyethyl starch solutions are colloids used for plasma volume replacement following acute blood loss. Disturbances of blood coagulation beyond dilution effects can occur rarely in hydroxyethyl starch solutions 1. This openlabel study was designed to investigate the pharmacokinetic and pharmacodynamic profiles of hextend in 21 healthy volunteers. Hydroxyethyl starch hes is widely used for fluid resuscitation in icus, but its safety and efficacy have not been established in patients with severe sepsis. Concerns over use of hydroxyethyl starch solutions ncbi. Hydroxyethyl starch is a synthetic colloid volume expander that is used to maintain vascular volume in animals with circulatory shock. Hydroxyethyl starch hes solutions are widely used to replace. Christiane hartog and colleagues discuss the evidence and call on doctors to avoid using starch formulations concerns about serious side effects. Hydroxyethylstarch solutions hes no longer to be used in patients with sepsis or burn injuries or in critically ill patients. For editorial issues, permissions, book requests, submissions and proceedings, contact. Use of the information, documents and data from the echa website is subject to the terms and conditions of this legal notice, and subject to other binding limitations provided for under applicable law, the information, documents and data made available on the echa website may be reproduced, distributed andor used, totally or in part, for noncommercial purposes provided that echa is.
The purpose of this public workshop is to discuss new information on the risks and benefits of fdaapproved hydroxyethyl starch hes solutions. Hydroxyethyl starch heshaes, sold under the brand name voluven among others, is a nonionic starch derivative, used as a volume expander in intravenous therapy. We performed the current study to investigate the influence of 2 different hydroxyethyl starch hes solutions, the novel medium molecular weight hes 0. A 6% concentration is commonly preferred with kd and 0. Hydroxyethyl starch solutions and patient harm the lancet. Hydroxyethyl starch in sodium chloride clinical pharmacology mechanism of action. Hydroxyethyl starch solutions and their effect on the. Voluven tetrastarch dosing, indications, interactions. The effects of hydroxyethyl starch solution in critically ill patients. Administer up to 50 mlkgday equivalent to 3 g hydroxyethyl starch and 7. Voluven hydroxyethyl starch in sodium chloride injection. Hydroxyethyl starch hes solutions are used for the treatment of hypovolemia low blood volume when plasma volume expansion is desired.
Hydroxyethyl starch hes containing medicinal products. Hydroxyethyl starch solution for extracorporeal tissue. These solutions are classified as crystalloids and colloids. Anaphylactoid reactions occur rarely in hydroxyethyl starch solutions. Hydroxyethyl starch hes is the most common red blood cell sedimentation agent used to purify. Find information on hydroxyethyl starch use, treatment, drug class and molecular. Fda warns of increased mortality risk with hes solution. Give initial 1020 ml by slow iv infusion and monitor for anaphylactoid reaction. Counter statement to open letter to the executive director of the european medicines agency concerning the licensing of hydroxyethyl starch solutions for fluid resuscitation.
Hydroxyethyl starch solutions in critically ill or septic patientsupdate 15. Letter to the editor moderate intraoperative use of hydroxyethyl starch solutions is safe pivalizza, evan g. With the release of a new, veterinarylabeled synthetic hydroxyethyl starch product, vetstarch 6% hydroxyethyl starch 0. The food and drug administration fda is announcing a public workshop entitled. Concerns about serious side effects of hydroxyethyl starch hes began to emerge in the 1970s, soon after it was first licensed. Lists the various brand names available for medicines containing hydroxyethyl starch. But lately it has been found that hydroxyethyl starchhes has a greater threat and risk of poor outcome in compared to other colloidal solutions. Any component of the pump participates in occurrence of these adverse events, one of which is the type of prime solution. Lowmolecularweight hes like voluven mw 000 have shown increased risk of aki and mortality in recent large randomized trials.
Hydroxyethyl starch hescontaining solutions are given by infusion drip into a vein and are used as volume expanders to replace lost fluids in critically ill patients with hypovolaemialow. In australia, two products that contain hydroxyethyl starch are registered on the australian register of therapeutic goods voluven and volulyte. Risks and benefits of hydroxyethyl starch solutions. Jones p a et al 2001 effect of hydroxyethyl starch infusion on colloid oncotic pressure in hypoproteinemic horses. Review of hydroxyethylstarchcontaining solutions for. Hydroxyethyl starch hes products are synthetic colloid solutions used for plasma volume expansion. Hydroxyethyl starch hes is one of the most studied plasma substitutes. Side effects of voluven hydroxyethyl starch in sodium. Pdf the effects of hydroxyethyl starch solution in critically ill patients.
Hydroxyethyl starch hes solutions like voluven, hespan or hextend 6% solution are widely used for the. Pdf should hydroxyethyl starch solutions be totally banned. Hydroxyethyl starchhes uses, side effects, substitutes. Annex i list of the names, pharmaceutical forms, strengths. Find information on hydroxyethyl starch use, treatment, drug class and molecular formula. The influence of two different hydroxyethyl starch. It can causes reactions like hypersensitivity, influenza, disturbances in coagulation, renal failure. In this study, we aimed to compare the effects of 6% hydroxyethyl starch 0.
Randomized trials of 6% tetrastarch hydroxyethyl starch 0. Recent data have associated the use of these products with an increased risk of severe adverse events when used in certain patient populations. The ongoing debate about the use of crystalloid versus colloid solutions has now shifted to a debate on the ideal type of colloid solution. Moderate intraoperative use of hydroxyethyl starch. Hydroxyethyl starch hes solutions for infusion should be removed from the market across europe because they carry serious risks, the european medicines agency ema has said. Fda warns of higher mortality risk with hydroxyethyl starch solution.
Trends have been movingaway from using hydroxyethyl starch solutions following concerns about safety. The larger molecules the range is from 10,000 to 2 million daltons of hespan are degraded by amylase. Hydroxyethyl starch is a nonionic starch derivative. Different kinds of hes solutions exist worldwide, which differ greatly in their pharmacological properties. Public citizen filed a petition pdf with the fda on february 8, calling for a recall of hydroxyethyl starch hes iv solutions, including hespan, hextend, and voluven.
The choice of fluids for intravascular volume replacement has been debated for. Extracorporeal perfusion, hydroxyethyl starch, free flap, ischemia. The concerns grew after three multicentre randomised trials found that administration of hes in patients who had sepsis or were critically ill was. The labels warnings and precautions section will advise clinicians to avoid using hes solutions in such. Search results for hydroxyethyl starch at sigmaaldrich. The cmdh 1 has decided that hydroxyethyl starch hes solutions for infusion should remain on the market provided that a combination of additional measures to protect patients is implemented. Hydroxyethylstarch solutions hes malaysian society of.
Hydroxyethyl starch in balanced electrolyte solution. Average of 1 oh group per 10 glucose units converted to och 2 ch 2 oh. Concentration mainly influences the initial volume effect. Clinical trials have reported an increased risk of renal dysfunction and mortality in critically ill or septic patients who received hydroxyethyl starch hes compared with crystalloids. Since the advent of cardiopulmonary bypass, many efforts have been made to avoid the complications related with it.
Resuscitation with intravenous fluid therapy is considered a corner stone in the management of critically ill patients in most acute conditions. Hydroxyethyl starch voluven and volulyte therapeutic. Hydroxyethyl starch, sodium chloride voluven hes 0,4 6 % infusionsloesung 60 gl, 9 gl solution for infusion intravenous use belgium fresenius kabi nv molenberglei 7 2627 schelle belgium hydroxyethyl starch haessteril 10% 100 mgml solution for infusion intravenous use belgium fresenius kabi nv molenberglei 7 2627 schelle. It is categorized based on its in vitro molecular weight.
Jones p a et al 1997 oncotic, hemodilutional, and hemostatic effects of isotonic saline and hydroxyethyl starch solutions in clinically normal ponies. The use of hes on critically ill patients is associated with an increased risk of death and kidney problems. They have been used instead of crystalloidssuch as salineto prevent shock. Hydroxyethyl starch is used in clinical situations, including during surgery, to treat and prevent a condition known as hypovolaemia. Review of hydroxyethylstarchcontaining solutions for infusion started. Why hydroxyethyl starch solutions should not be banned from the.
Ema calls for hydroxyethyl starch solutions to be taken. Hydroxyethyl starch in sodium chloride fda prescribing. The hesfamily differ widely in their physicochemical and pharmacokinetic properties, composition, and adverse effect profiles table 1, figure 2. The dilemma for using hydroxyethyl starch solutions for. Hydroxyethylstarch solutions hes should no longer be used in patients with sepsis or burn injuries or in critically ill patients cmdh endorses prac. Butare the available data sufficient to clearly assess the riskbenefit balance for allpatients, and is there enough evidence of harm to justify removing these. Hydroxyethyl starch iv solution recall urged due to life.
It is a modified branchedchain glucose polymer derived from amylopectin sources such as potatoes, sorghum, or maize. Ccsap 2018 book 3 fluids and nutritiongi and liver disorders 7 fluid and hyponatremia management. For the in vitro experiments, blood was incubated with increasing concentrations 0%50% volvol plasma of either. Large trials have shown that hydroxyethyl starch increases the risk of death, kidney injury, and bleeding. The effects of hydroxyethyl starch solution in critically. Should hydroxyethyl starch solutions be totally banned. Concerns over use of hydroxyethyl starch solutions the bmj.