Hydroxyethyl starch 130/0.38-0.45 versus crystalloid or albumin in patients with sepsis: systematic review with meta-analysis and trial sequential analysis
Open accessAbstract
OBJECTIVE: To assess the effects of fluid therapy with hydroxyethyl starch 130/0.38-0.45 versus crystalloid or albumin on mortality, kidney injury, bleeding, and serious adverse events in patients with sepsis. DESIGN: Systematic review with meta-analyses and trial sequential analyses of randomised clinical trials. DATA SOURCES: Cochrane Library, Medline, Embase, Biosis Previews, Science Citation Index Expanded, CINAHL, Current Controlled Trials, Clinicaltrials.gov, and Centerwatch to September 2012; hand search of reference lists and other systematic reviews; contact with authors and relevant pharmaceutical companies. STUDY SELECTION: Eligible trials were randomised clinical trials comparing hydroxyethyl starch 130/0.38-0.45 with either crystalloid or human albumin in patients with sepsis. Published and unpublished trials were included irrespective of language and predefined outcomes. DATA EXTRACTION: Two reviewers independently assessed studies for inclusion and extracted data on methods, interventions, outcomes, and risk of bias. Risk ratios and mean differences with 95% confidence intervals were estimated with fixed and random effects models. RESULTS: Nine trials that randomised 3456 patients with sepsis were included. Overall, hydroxyethyl starch 130/0.38-0.45 versus crystalloid or albumin did not affect the relative risk of death (1.04, 95% confidence interval 0.89 to 1.22, 3414 patients, eight trials), but in the predefined analysis of trials with low risk of bias the relative risk of death was 1.11 (1.00 to 1.23, trial sequential analysis (TSA) adjusted 95% confidence interval 0.95 to 1.29, 3016 patients, four trials). In the hydroxyethyl starch group, renal replacement therapy was used more (1.36, 1.08 to 1.72, TSA adjusted 1.03 to 1.80, 1311 patients, five trials), and the relative risk of acute kidney injury was 1.18 (0.99 to 1.40, TSA adjusted 0.90 to 1.54, 994 patients, four trials). More patients in the hydroxyethyl starch group were transfused with red blood cells (1.29, 1.13 to 1.48, TSA adjusted 1.10 to 1.51, 973 patients, three trials), and more patients had serious adverse events (1.30, 1.02 to 1.67, TSA adjusted 0.93 to 1.83, 1069 patients, four trials). The transfused volume of red blood cells did not differ between the groups (mean difference 65 mL, 95% confidence interval -20 to 149 mL, three trials). CONCLUSION: In conventional meta-analyses including recent trial data, hydroxyethyl starch 130/0.38-0.45 versus crystalloid or albumin increased the use of renal replacement therapy and transfusion with red blood cells, and resulted in more serious adverse events in patients with sepsis. It seems unlikely that hydroxyethyl starch 130/0.38-0.45 provides overall clinical benefit for patients with sepsis.
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Smaller studies suggest that source control within 6 to 12 hours is advantageous.
“While there are limited data to conclusively issue a recommendation regarding the timeframe in which source control should be obtained, smaller studies suggest that source control within 6 to 12 hours is advantageous (265-271).”
From Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. (2021) · cites this paper as [269]
The Results section’s trial-characteristics table describes studies of hydroxyethyl starch versus crystalloid or albumin for resuscitation, not studies of when to obtain source control (page unavailable). Searches for “source control within 6 to 12 hours” and for timing of drainage or surgery in sepsis found no passage addressing the claimed advantage. (LLM, conf=0.76)
Experimental — accuracy not yet measuredA previous meta-analysis of RCTs in septic patients showed higher risk of renal replacement therapy with HES 130/0.38-0.45 and higher risk of death in low risk of bias trials.
“A previous meta-analysis of RCTs in septic patients showed a higher risk of RRT with the use of HES 130/0.38–0.45 (RR 1.36; 95% CI 1.08–1.72) and a higher risk of death in a pre-defined analysis of low risk of bias trials (RR 1.11; 95% CI 1.0–1.2) [343].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [343]
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- Authors
- Haase, N., Perner, A., Hennings, L. I., Siegemund, M., Lauridsen, B., Wetterslev, M., & Wetterslev, J.
- Affiliations
- Copenhagen University Hospital (DK)
- Kantonsspital Baden (CH)
- Corresponding author
- Haase, N.
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2013-02-15
- Volume
- 346
- Issue
- feb15 1
- Pages
- f839-f839
- ISSN
- 1756-1833 (ISSN-L)
- PMC
- PMC3573769
- OpenAlex
- W2166328186
- Cited by
- 310
- References
- 77
- Citations by year
- 2026: 5 · 2025: 6 · 2024: 9 · 2023: 8 · 2022: 11 · 2021: 15 · 2020: 31 · 2019: 16 · 2018: 16 · 2017: 24 · 2016: 33 · 2015: 41 · 2014: 54 · 2013: 38
- FWCI
- 6.56
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Sepsis Diagnosis and Treatment
- Health Sciences › Medicine › Nephrology › Acute Kidney Injury Research
- Health Sciences › Medicine › Surgery › Hemodynamic Monitoring and Therapy
- Keywords
- sepsis, fluid resuscitation, crystalloids, human serum albumin, mortality, acute kidney injury, renal replacement therapy, hemorrhage, serious adverse events, trial sequential analysis, risk of bias, risk of bias adjustment
- MeSH terms
- Crystalloid Solutions, Fluid Therapy, Humans, Hydroxyethyl Starch Derivatives, Isotonic Solutions, Serum Albumin, Sepsis
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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