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01-12-2012 | Letter

CRYSTMAS study adds to concerns about renal safety and increased mortality in sepsis patients

Authors: Christiane S Hartog, Konrad Reinhart

Published in: Critical Care | Issue 6/2012

Excerpt

The CRYSTMAS trial compared resuscitation fluids 6% HES 130/0.4 and 0.9% NaCl in patients with severe sepsis to fulfil a postmarketing study commitment issued by the US Food and Drug Administration (FDA). However, published trial outcomes were selective. When the more complete data set is assessed and compared against previous data, it rather suggests that use of HES 130/0.4 does not lead to clinically relevant volume savings, and suggests similar negative effects on kidney function as were seen with an older HES solution and an increase in 90-day mortality by 6.8%. …

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Guidet B, Martinet O, Boulain T, Philippart F, Poussel JF, Maizel J, Forceville X, Feissel M, Hasselmann M, Heininger A, Van Aken H: Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study. Crit Care 2012, 16: R94. 10.1186/cc11358PubMedCentralCrossRefPubMed

Perner A, Haase N, Wetterslev J, Aneman A, Tenhunen J, Guttormsen AB, Klemenzson G, Pott F, Bødker KD, Bådstøløkken PM, Bendtsen A, Søe-Jensen P, Tousi H, Bestle M, Pawlowicz M, Winding R, Bülow HH, Kancir C, Steensen M, Nielsen J, Fogh B, Madsen KR, Larsen NH, Carlsson M, Wiis J, Petersen JA, Iversen S, Schøidt O, Leivdal S, Berezowicz P, et al.: Comparing the effect of hydroxyethyl starch 130/0.4 with balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis (6S - Scandinavian Starch for Severe Sepsis/Septic Shock trial): study protocol, design and rationale for a double-blinded, randomised clinical trial. Trials 2011, 12: 24. 10.1186/1745-6215-12-24PubMedCentralCrossRefPubMed

Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K, German Competence Network Sepsis (SepNet): Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med 2008, 358: 125-139. 10.1056/NEJMoa070716CrossRefPubMed

Package insert Voluven[http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/NewDrugApplicationsNDAs/UCM083138.pdf]

McGauran N, Wieseler B, Kreis J, Schuler YB, Kolsch H, Kaiser T: Reporting bias in medical research - a narrative review. Trials 2010, 11: 37. 10.1186/1745-6215-11-37PubMedCentralCrossRefPubMed

Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis (CRYSTMAS). NLM Identifier: NCT00464204[http://clinicaltrials.gov/ct2/show/study/NCT00464204?sect=Xji8015]

Title: CRYSTMAS study adds to concerns about renal safety and increased mortality in sepsis patients
Authors: Christiane S Hartog
Konrad Reinhart
Publication date: 01-12-2012
Publisher: BioMed Central
Published in: Critical Care / Issue 6/2012
Electronic ISSN: 1364-8535
DOI: https://doi.org/10.1186/cc11673

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