Fresenius Blood Volumizer Linked to Deaths in Study

A product made by Fresenius SE to boost blood volume in critically ill patients increases the risk of death and kidney damage, according to an analysis of previous studies that excluded data from a discredited researcher.

In an analysis of 38 trials, patients who got an infusion of hydroxyethyl starch solution weren’t any less likely to die than those treated with other blood volume boosters, the study by Canadian researchers found. However, when data was excluded from seven studies by a German doctor whose research has been widely retracted, the infusion was associated with a bigger risk of death and kidney injury.

The study, published in the Journal of the American Medical Association, highlights a debate about which fluid is best used to resuscitate emergency and operating room patients whose blood pressure has plummeted. The analysis combined several recent studies with existing research to indicate that despite being more expensive than a salt solution, hydroxyethyl starch may not be better, said Ryan Zarychanski, the study author.

“We need to ask ourselves why we’re using these products so liberally and in such an unrestricted manner,´´ Zarychanski, an assistant professor in the Department of Internal Medicine at the University of Manitoba, said in a telephone interview.

Fresenius, based in Bad Homburg, Germany, is the top seller of hydroxyethyl starch. Closely held B. Braun Holding GmbH, based in Melsungen, Germany, also makes the product.

Matthias Link, a spokesman for Fresenius, and Wolfgang Schrammel, a spokesman for Braun declined to comment.

Safety Concern

Until additional randomized trials can be run, the study suggests that hydroxyethyl starch ‘‘should not be used for acute volume resuscitation of critically ill patients,’’ Massimo Antonelli, of the Institute of Intensive Care Medicine and Anesthesiology at the Policlinico Universitario A. Gemelli, wrote in an accompanying editorial.

Zarychanski’s research team analyzed trials that compared hydroxyethyl starch with other intravenous fluids in 10,868 patients. The researchers ran the data twice, once to include seven studies by German researcher Joachim Boldt and once without Boldt’s work.

Eighty-eight of Boldt’s 102 studies published since 1999 were retracted due to research misconduct after an investigation of the State Medical Association of Rheinland-Pfalz in 2011.

The seven studies excluded from today’s survey predated 1999, Zarychanski said.

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