Trial reportIntensive care medicine2013
Bleeding and risk of death with hydroxyethyl starch in severe sepsis: post hoc analyses of a randomized clinical trial.
Trial report in Intensive care medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.
- Colloids versus crystalloids for fluid resuscitation in critically ill people.The Cochrane database of systematic reviews · 2018Pooled it
- Immunoglobulin G for patients with necrotising soft tissue infection (INSTINCT): a randomised, blinded, placebo-controlled trial.Intensive care medicine · 2017Trial
- Long-term outcomes in patients with septic shock transfused at a lower versus a higher haemoglobin threshold: the TRISS randomised, multicentre clinical trial.Intensive care medicine · 2016Trial
- 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
- A phase I trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenously administered low-anticoagulant heparin (M6229) in critically ill sepsis patients.Intensive care medicine experimental · 2025Article
- 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
- Thromboembolic and bleeding events in ICU patients with COVID-19: A nationwide, observational study.Acta anaesthesiologica Scandinavica · 2023Observational
- P(v-a)COBMJ open · 2022Article
- Sepsis associated acute kidney injury.BMJ (Clinical research ed.) · 2019Review
- Starch Wars-New Episodes of the Saga. Changes in Regulations on Hydroxyethyl Starch in the European Union.Frontiers in veterinary science · 2018Review
- Risks of bleeding and thrombosis in intensive care unit patients with haematological malignancies.Annals of intensive care · 2017Article
- Is the literature inconclusive about the harm from HES? No.Intensive care medicine · 2017Article
- The intensive care medicine research agenda on septic shock.Intensive care medicine · 2017Review
- Stress ulcer prophylaxis versus placebo or no prophylaxis in adult hospitalised acutely ill patients-protocol for a systematic review with meta-analysis and trial sequential analysis.Systematic reviews · 2017Article
- Intraoperative hydroxyethyl starch 70/0.5 administration may increase postoperative bleeding: a retrospective cohort study.Journal of anesthesia · 2017Article
- Should all septic patients be given systemic anticoagulation? No.Intensive care medicine · 2017Article
- Focus on transfusion, bleeding and thrombosis.Intensive care medicine · 2016Article
- Shock Management for Cardio-surgical ICU Patients - The Golden Hours.Cardiac failure review · 2015Article
- Testing current practice is no mistake.Intensive care medicine · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeWe aimed to characterize the degree and clinical importance of bleeding in patients treated with hydroxyethyl starch (HES).
methodsIn post hoc analyses, we examined the associations between fluid assignment, hemostatic variables, bleeding events, transfusions, and death among 798 patients with severe sepsis randomized to fluid resuscitation with HES 130/0.42 versus Ringer's acetate. We used Cox regression analysis adjusted for fluid assignment and baseline characteristics.
resultsOverall, 93 (23 %) patients assigned to HES versus 60 (15 %) patients assigned to Ringer's acetate bled in the ICU (relative risk (RR) 1.55; 95 % CI 1.16-2.08; P = 0.003). Of these, 38 and 25 (RR 1.52; 95 % CI 0.94-2.48; P = 0.09), respectively, had severe bleeding (intracranial or concomitant transfusion with three units of red blood cells). Most patients bled in the first days after randomization when most trial fluid was given. The hazards ratios for occurrence of any bleeding and severe bleeding in patients treated with HES versus Ringer's acetate were 1.70 (95 % CI 1.23-2.36; P = 0.001) and 1.55 (95 % CI 0.93-2.56; P = 0.09), respectively. The adjusted hazard ratios for death among patients with any bleeding and severe bleeding compared to those without bleeding were 1.36 (95 % CI 1.04-1.79; P = 0.03) and 1.74 (95 % CI 1.20-2.53; P = 0.004), respectively.
conclusionsIn post hoc analyses of patient with severe sepsis, treatment with HES increased the risk of bleeding which was associated with increased risk of death. HES-induced bleeding complications may negatively affect outcome in patients with severe sepsis.
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