All you need to read in the other general journalsBMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e4517 (Published 04 July 2012) Cite this as: BMJ 2012;345:e4517
Hydroxyethyl starch linked to excess deaths from acute severe sepsis
More safety concerns about the colloid hydroxyethyl starch (HES) have emerged from a randomised trial of adults with severe sepsis⇑. Those given HES 130/0.4 for volume expansion were significantly more likely to die than controls given Ringer’s acetate solution (51% (201/398) v 43% (172/400); relative risk 1.17, 95% CI 1.01 to 1.36). They were also more likely to need renal replacement treatment during 90 days of follow-up (22% (87/398) v 16% (65/400); 1.35 1.01 to 1.80).
The authors recruited patients from 26 intensive care units in Scandinavian hospitals and allowed local doctors to make all treatment decisions except choice and maximum volume of resuscitation fluid. They tested a hydroxyethyl starch solution with a lower molecular weight than traditional starch solutions to find out if the different formulation would be safer. It wasn’t. The colloid caused an excess of deaths in both per protocol and intention to treat analyses, with an estimated number needed to harm of just 13. Adults resuscitated with HES 130/0.4 needed more blood products than did controls. Both groups received about the same volumes of resuscitation fluid overall. The trial was double blind and independently funded.
Results were broadly in line with the results of smaller trials testing older formulations of HES. The increased mortality took about a month to emerge, and the authors suggest that toxic effects of HES on kidney, liver, and bone marrow were responsible for the late extra deaths. Participants had a mean age of 66 years, and 84% were in shock when randomised. The lungs and abdomen were the most common sources of sepsis.