Concerns over use of hydroxyethyl starch solutions

In his critisism of the analysis by Hartog and co-authors dr. Priebe [1] misquotes the results of the 6S trial [2] saying that the increased mortality with starch was not observed in the modified intention to treat population. This is incorrect. In the 6S trial the relative increased risk for 90-day mortality of starch vs. crystalloid was 1.17 (95% CI 1.01-1.36, P=0.03) in the modified intention to treat population [2].

Thus the conclusion of the NEJM paper was correctly that 'Patients with severe sepsis assigned to fluid resuscitation with HES 130/0.42 had an
increased risk of death at day 90 and were more likely to require renal-replacement therapy, as compared with those receiving Ringer’s acetate.'

References

1. Priebe H-J: Re: Concerns over use of hydroxyethyl starch solutions. BMJ www.bmj.com/content/349/bmj.g5981/rr/780331, 2014.

2. Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Åneman A, Madsen KR, Møller MH, Elkjær JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Søe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjældgaard A-L, Fabritius ML, Mondrup F, Pott FC, Møller TP, Winkel P, Wetterslev J: Hydroxyethyl starch 130/0.4 versus Ringer’s acetate in severe sepsis. N Engl J Med 367:124-134, 2012.