Hydroxyethyl starch linked to serious adverse events

CHICAGO – In an analysis* of studies that examined critically ill patients requiring an increase in blood fluid volume, intravenous use of the fluid hydroxyethyl starch, compared with other resuscitation solutions, was not associated with decreased mortality, according to an article appearing in the February 20 issue of JAMA. Moreover, after exclusion of 7 trials performed by an investigator whose research has been retracted because of scientific misconduct, the analysis of the remaining studies indicated that hydroxyethyl starch was associated with a significant increased risk of death and acute kidney injury.

“Fluids are a core element in the resuscitation of critically ill patients and the relative superiority and safety of different resuscitation solutions has been the focus of considerable debate,” according to background information in the article. “Hydroxyethyl starch is commonly used for volume resuscitation yet has been associated with serious adverse events, including acute kidney injury and death. Clinical trials of hydroxyethyl starch are conflicting. Moreover, multiple trials from one investigator have been retracted because of scientific misconduct.”

According to the article, “In 2011, 86 percent (88 of 102) of the research published by Joachim Boldt, M.D., since 1999 was retracted after a government investigation reported research misconduct reflecting failure to acquire ethical approval for research and fabrication of study data. The effect of these retractions has been far-reaching. All major systematic reviews and clinical guidelines are now being revised to account for the retracted data and permit sensitivity analyses on the remaining publications by Boldt et al.”

Ryan Zarychanski, M.D., M.Sc., of the University of Manitoba, Canada, and colleagues performed a systematic review and meta-analysis of randomizAir Jordan I Mid