Trial reportTrials2011
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.
Trial report in Trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00962156 (Effects of Hydroxyethyl Starch 130/0.4 Compared With Balanced Crystalloid Solution on Mortality and Kidney Failure in Patients With Severe Sepsis), which is not on this map. Cited by 24 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effects of Hydroxyethyl Starch 130/0.4 Compared With Balanced Crystalloid Solution on Mortality and Kidney Failure in Patients With Severe Sepsis
Who cites it
24 citing papers in PubMed, 5 syntheses or guidelines pooled it, 62 citations in OpenAlex.
- Colloids versus crystalloids for fluid resuscitation in critically ill people.The Cochrane database of systematic reviews · 2018Pooled it
- Diagnosis and prognosis of neutrophil gelatinase-associated lipocalin for acute kidney injury with sepsis: a systematic review and meta-analysis.Critical care (London, England) · 2016Pooled it
- Albumin versus crystalloid solutions in patients with the acute respiratory distress syndrome: a systematic review and meta-analysis.Critical care (London, England) · 2014Pooled it
- Management of bleeding and coagulopathy following major trauma: an updated European guideline.Critical care (London, England) · 2013Pooled it
- Clinical review: Volume of fluid resuscitation and the incidence of acute kidney injury - a systematic review.Critical care (London, England) · 2012Pooled it
- Trial
- Long-term outcomes in patients with severe sepsis randomised to resuscitation with hydroxyethyl starch 130/0.42 or Ringer's acetate.Intensive care medicine · 2014Trial
- Bleeding and risk of death with hydroxyethyl starch in severe sepsis: post hoc analyses of a randomized clinical trial.Intensive care medicine · 2013Trial
- Effects of hydroxyethyl starch in subgroups of patients with severe sepsis: exploratory post-hoc analyses of a randomised trial.Intensive care medicine · 2013Trial
- Quality of life and pruritus in patients with severe sepsis resuscitated with hydroxyethyl starch long-term follow-up of a randomised trial.Critical care (London, England) · 2013Trial
- 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.Critical care (London, England) · 2012Trial
- The influence of fluid resuscitation strategy on outcomes from dengue shock syndrome: a review of the management of 691 children in 7 Southeast Asian hospitals.BMJ global health · 2025Article
- Evaluation of hyperbranched polyglycerol for cold perfusion and storage of donor kidneys in a pig model of kidney autotransplantation.Journal of biomedical materials research. Part B, Applied biomaterials · 2021Article
- The effects of hydroxyethyl starch and gelatine on pulmonary cytokine production and oedema formation.Scientific reports · 2018Article
- Cold preservation with hyperbranched polyglycerol-based solution improves kidney functional recovery with less injury at reperfusion in rats.American journal of translational research · 2017Article
- Article
- Thromboelastography in patients with severe sepsis: a prospective cohort study.Intensive care medicine · 2015Observational
- The thresholds for statistical and clinical significance - a five-step procedure for evaluation of intervention effects in randomised clinical trials.BMC medical research methodology · 2014Article
- Effect of 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (Voluven®) on complications after subarachnoid hemorrhage: a retrospective analysis.SpringerPlus · 2013Article
- Debate on HES safety is important, but must be based on facts.Scandinavian journal of trauma, resuscitation and emergency medicine · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
41 authors at 18 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBy tradition colloid solutions have been used to obtain fast circulatory stabilisation in shock, but high molecular weight hydroxyethyl starch (HES) may cause acute kidney failure in patients with severe sepsis. Now lower molecular weight HES 130/0.4 is the preferred colloid in Scandinavian intensive care units (ICUs) and 1st choice fluid for patients with severe sepsis. However, HES 130/0.4 is largely unstudied in patients with severe sepsis. METHODS/
designThe 6S trial will randomize 800 patients with severe sepsis in 30 Scandinavian ICUs to masked fluid resuscitation using either 6% HES 130/0.4 in Ringer's acetate or Ringer's acetate alone. The composite endpoint of 90-day mortality or end-stage kidney failure is the primary outcome measure. The secondary outcome measures are severe bleeding or allergic reactions, organ failure, acute kidney failure, days alive without renal replacement therapy or ventilator support and 28-day and 1/2- and one-year mortality. The sample size will allow the detection of a 10% absolute difference between the two groups in the composite endpoint with a power of 80%. DISCUSSION: The 6S trial will provide important safety and efficacy data on the use of HES 130/0.4 in patients with severe sepsis. The effects on mortality, dialysis-dependency, time on ventilator, bleeding and markers of resuscitation, metabolism, kidney failure, and coagulation will be assessed.
trial registrationClinicalTrials.gov: NCT00962156.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.