Trial reportThe New England journal of medicine2012
Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis.
Trial report in The New England journal of medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 6 registered trials, which are not on this map. Cited by 552 papers, 17 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
Phase IV, Multicentric, Prospective, Controlled, Randomized, Double Blind Study Comparing a Crystalloid to a Colloid Used in the Perioperatory Hemodynamic Optimisation With a 'Closed Loop' Automatic Filling System, on the Post-surgery Morbidity in Major Abdominal Surgery.
Effect of Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function; A Randomized Open Label Controlled Study
Glycocalyx Levels in Patients Undergoing Pancreatectomy With Human Albumin 5% vs. Gelofusine
Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management: a Multicentric, Randomized, Controlled, Open Label Pilot-study
Efficacy and Safety of Balanced Gelatin Solution for Fluid Infusion in Sepsis Patients Undergoing Emergency Abdominal Surgery: A Multicenter, Adaptive Designed, Randomized Controlled Trial
Who cites it
552 citing papers in PubMed, 17 syntheses or guidelines pooled it, 1,823 citations in OpenAlex.
- Targeting capillary leak in experimental sepsis and endotoxemia: a systematic review of therapeutic agents, methods and models in animal studies.Critical care (London, England) · 2026Pooled it
- Effect of Albumin Concentration and Timing on Acute Kidney Injury After Adult Cardiac Surgery: A Systematic Review and Meta-analysis.Annals of cardiac anaesthesia · 2026Pooled it
- Prevalence and representation of comorbidities and multimorbidity in randomised controlled trials in sepsis or septic shock: a systematic review.Critical care (London, England) · 2026Pooled it
- Sex and gender considerations in randomized controlled trials in critical care nephrology: a meta-epidemiologic study.BMC medicine · 2025Pooled it
- Fluid resuscitation in adults with severe infection and sepsis: a systematic review and network meta-analysis.Frontiers in medicine · 2025Pooled it
- Clinical efficacy of various resuscitation fluids in the management of sepsis in postoperative surgical and trauma patients: a systematic review and meta--analysis.Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques · 2024Pooled it
- Physical and Chemical Compatibility of Medications Commonly Used in Critically Ill Patients With Balanced Crystalloids: A Systematic Review.The Annals of pharmacotherapy · 2024Pooled it
- Effects of albumin and crystalloid priming strategies on red blood cell transfusions in on-pump cardiac surgery: a network meta-analysis.BMC anesthesiology · 2024Pooled it
- A Systematic Bibliometric Analysis of High-Impact Articles in Critical Care Nephrology.Blood purification · 2024Pooled it
- Pooled it
- Acetate- versus lactate-buffered crystalloid solutions: A systematic review with meta-analysis and trial sequential analysis.Acta anaesthesiologica Scandinavica · 2022Pooled it
- Comparison of colloid and crystalloid using goal-directed fluid therapy protocol in non-cardiac surgery: a meta-analysis of randomized controlled trials.Journal of anesthesia · 2020Pooled it
- Controversies in acute kidney injury: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Conference.Kidney international · 2020 · on this mapGuideline
- Perioperative Clinical Trials in AKI.Seminars in nephrology · 2020Pooled it
- Surviving sepsis campaign international guidelines for the management of septic shock and sepsis-associated organ dysfunction in children.Intensive care medicine · 2020Guideline
- Pooled it
- Trends in sepsis mortality over time in randomised sepsis trials: a systematic literature review and meta-analysis of mortality in the control arm, 2002-2016.Critical care (London, England) · 2019Pooled it
- Transthoracic echocardiographic evaluation of maternal cardiac output: colloid preload versus crystalloid coload during cesarean delivery under spinal anesthesia: randomized clinical trial.BMC anesthesiology · 2026Trial
- Safety and efficacy of 6% hydroxyethyl starch in patients undergoing major surgery: The randomised controlled PHOENICS trial.European journal of anaesthesiology · 2026Trial
- Impact on fluid balance of an optimized restrictive strategy targeting non-resuscitative fluids in intensive care patients with septic shock: a single-blind, multicenter, randomized, controlled, pilot study.Critical care (London, England) · 2024Trial
492 more citing papers are in PubMed but not listed here.
Corrections and comments
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- Erratum issued
Authors and funding
34 authors at 9 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHydroxyethyl starch (HES) [corrected] is widely used for fluid resuscitation in intensive care units (ICUs), but its safety and efficacy have not been established in patients with severe sepsis.
methodsIn this multicenter, parallel-group, blinded trial, we randomly assigned patients with severe sepsis to fluid resuscitation in the ICU with either 6% HES 130/0.42 (Tetraspan) or Ringer's acetate at a dose of up to 33 ml per kilogram of ideal body weight per day. The primary outcome measure was either death or end-stage kidney failure (dependence on dialysis) at 90 days after randomization.
resultsOf the 804 patients who underwent randomization, 798 were included in the modified intention-to-treat population. The two intervention groups had similar baseline characteristics. At 90 days after randomization, 201 of 398 patients (51%) assigned to HES 130/0.42 had died, as compared with 172 of 400 patients (43%) assigned to Ringer's acetate (relative risk, 1.17; 95% confidence interval [CI], 1.01 to 1.36; P=0.03); 1 patient in each group had end-stage kidney failure. In the 90-day period, 87 patients (22%) assigned to HES 130/0.42 were treated with renal-replacement therapy versus 65 patients (16%) assigned to Ringer's acetate (relative risk, 1.35; 95% CI, 1.01 to 1.80; P=0.04), and 38 patients (10%) and 25 patients (6%), respectively, had severe bleeding (relative risk, 1.52; 95% CI, 0.94 to 2.48; P=0.09). The results were supported by multivariate analyses, with adjustment for known risk factors for death or acute kidney injury at baseline.
conclusionsPatients 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. (Funded by the Danish Research Council and others; 6S ClinicalTrials.gov number, NCT00962156.).
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Registered trials
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.