Effects of an early restrictive versus liberal fluid strategy on long-term patient-centered outcomes in sepsis-induced hypotension: an open-label, randomized controlled trial
Authors' conclusion
In this long-term follow-up of a randomized controlled trial of patients with sepsis-induced hypotension, the restrictive fluid strategy used in this study resulted in similar cognitive and physical function at 6 and 12 months, compared to a liberal fluid strategy.
Study context
- Population
- Patients with sepsis-induced hypotension in the CLOVERS trial702 analysed at 6 months
- Participants
- 898 patients
- Comparison
- Early restrictive vs liberal fluid resuscitation strategy
Methodological detailsopen-label, prospective long-term follow-up, pre-specified analyses, trimmed means at 50%, 196 lost to follow-up; 431 survivors and 271 non-survivors analysed at 6 months
- Open-label
- Prospective long-term follow-up
- Pre-specified analyses
- Trimmed means at 50%
- 196 lost to follow-up; 431 survivors and 271 non-survivors analysed at 6 months
Primary result
As reported in the abstract
Functional outcomes at 6 months · 6 months
Restrictive vs LiberalEstimate (95% CI)
Executive function
trimmed mean difference(Hayling Sentence Completion Test) 0.38 (−0.97-1.76)
Health-related quality of life
trimmed mean difference(EQ-5D-5L) −0.01 (−0.07-0.06)
- Cognitive function
- trimmed mean difference (Montreal Cognitive Assessment-Blind Score) 0.11 (95% CI −1.44-1.70)
- Disability status
- trimmed mean difference (Activity of Daily Living Score) 0.03 (95% CI −0.84-0.90)
- Mobility
- trimmed mean difference (PROMIS Mobility Score) 0.72 (95% CI −2.20-3.64)
Further findings
Functional outcomes at 12 months
- Outcomes did not differ at 12 months
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Effects of an early restrictive versus liberal fluid strategy on long-term patient-centered outcomes in sepsis-induced hypotension: an open-label, randomized controlled trial. Am J Respir Crit Care Med. Published 6 May 2026. doi:10.
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