Biomaterial Database

Starch safety in resuscitation - when will we ever learn? 2013

Andy Parrish, and Marc Blockman

Department of Internal Medicine, Frere and Cecilia Makiwane Hospitals, East London, South Africa. andygp@mweb.co.za

Recent trials have failed to demonstrate a survival benefit from the use of hydroxyethyl starches (HES) as a colloid in fluid resuscitation and have raised concerns of renal harm. In severe sepsis, there is a concerning signal of increased mortality. New high-quality systematic reviews consistently demonstrate a statistically non-significant relative risk of death of 1.08 - 1.10 and a significant 25% increased chance of requiring renal replacement therapy. The HES literature contains many industry-affiliated reviews of indifferent quality. Traditional efficacy confidence limits may warrant re-evaluation when considering these harms. Newer formulations of HES and more focused indications for use show benefit on surrogate endpoints, but these trials are currently underpowered to ensure safety.

UI	MeSH Term	Description	Entries
D010952	Plasma Substitutes	Any liquid used to replace blood plasma, usually a saline solution, often with serum albumins, dextrans or other preparations. These substances do not enhance the oxygen- carrying capacity of blood, but merely replace the volume. They are also used to treat dehydration.	Blood Expanders,Plasma Volume Expanders,Expanders, Blood,Expanders, Plasma Volume,Substitutes, Plasma,Volume Expanders, Plasma
D012151	Resuscitation	The restoration to life or consciousness of one apparently dead. (Dorland, 27th ed)	Resuscitations
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D003102	Colloids	Two-phase systems in which one is uniformly dispersed in another as particles small enough so they cannot be filtered or will not settle out. The dispersing or continuous phase or medium envelops the particles of the discontinuous phase. All three states of matter can form colloids among each other.	Hydrocolloids,Colloid,Hydrocolloid
D005440	Fluid Therapy	Therapy whose basic objective is to restore the volume and composition of the body fluids to normal with respect to WATER-ELECTROLYTE BALANCE. Fluids may be administered intravenously, orally, by intermittent gavage, or by HYPODERMOCLYSIS.	Oral Rehydration Therapy,Rehydration,Rehydration, Oral,Oral Rehydration,Rehydration Therapy, Oral,Therapy, Fluid,Therapy, Oral Rehydration,Fluid Therapies,Oral Rehydration Therapies,Oral Rehydrations,Rehydration Therapies, Oral,Rehydrations,Rehydrations, Oral,Therapies, Fluid,Therapies, Oral Rehydration
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D006895	Hydroxyethyl Starch Derivatives	Starches that have been chemically modified so that a percentage of OH groups are substituted with 2-hydroxyethyl ether groups.	Hetastarch,Elohes,HAES-steril,Hemohes,Hespan,Hydroxyethyl Starch (130 KD-0.4 Substitution),Hydroxyethyl Starch 130-0.4,Hydroxyethylated Starches,Pentafraction,Pentaspan,Pentastarch,Plasmasteril,Starches, 2-Hydroxyethyl,2-Hydroxyethyl Starches,Derivatives, Hydroxyethyl Starch,Hydroxyethyl Starch 130 0.4,Starch Derivatives, Hydroxyethyl,Starches, 2 Hydroxyethyl,Starches, Hydroxyethylated
D061214	Patient Safety	Efforts to reduce risk, to address and reduce incidents and accidents that may negatively impact healthcare consumers.	Patient Safeties,Safeties, Patient,Safety, Patient
D018805	Sepsis	Systemic inflammatory response syndrome with a proven or suspected infectious etiology. When sepsis is associated with organ dysfunction distant from the site of infection, it is called severe sepsis. When sepsis is accompanied by HYPOTENSION despite adequate fluid infusion, it is called SEPTIC SHOCK.	Bloodstream Infection,Pyaemia,Pyemia,Pyohemia,Blood Poisoning,Poisoning, Blood,Septicemia,Severe Sepsis,Blood Poisonings,Bloodstream Infections,Infection, Bloodstream,Poisonings, Blood,Pyaemias,Pyemias,Pyohemias,Sepsis, Severe,Septicemias