- Design
- Systematic review and meta-analysis of RCTs with trial sequential analysis
- Population
- 13,951 surgical patients in 114 trials receiving HES 130/0.4 or 130/0.42
- Primary outcome
- Acute kidney injury and creatinine change
- Effect
- AKI RR 1.02 (0.91 to 1.16); creatinine -0.62 µmol/l (-3.82 to 2.57)
HES carries an FDA boxed warning extended to surgical patients in 2021, and the European Medicines Agency began withdrawing it in 2022, based on renal harm in critically ill and septic patients. This meta-analysis pooled 114 randomised trials (13,951 surgical patients, 2009 to 2026) using HES 130/0.4 or 130/0.42, nearly all for under 24 hours.
HES did not increase acute kidney injury (RR 1.02, 95% CI 0.91 to 1.16) or change creatinine (-0.62 µmol/l, -3.82 to 2.57). Trial sequential analysis supported non-inferiority for creatinine. Mortality and serious adverse events were not worsened. Most trials were at low risk of bias.
The finding challenges extending ICU data to short perioperative use. But regulatory warnings remain in force, and the evidence does not apply to septic or critically ill patients.
- Follow the current regulatory position on HES, which this study does not change
- Never use HES in sepsis, critical illness or pre-existing renal impairment
- In surgery, short-term HES 130/0.4 was not associated with kidney injury in trials
- Balanced crystalloids remain the default perioperative fluid
Why it matters
It questions whether ICU harms should have been extended to short perioperative use.
Don't overread it
This does not overturn the FDA warning or EMA restrictions, and gives no reassurance for septic or critically ill patients.
The statistics, in plain English
A relative risk of 1.02 with an interval from 0.91 to 1.16 means any increase in kidney injury, if present, is likely small. Trial sequential analysis suggests enough patients have been studied for the creatinine result.
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