Sepsis & infection

Early Restrictive or Liberal Fluid Management for Sepsis-Induced Hypotension

N Engl J MedPublished Randomised controlled trial

Primary resultResult — go to the resultEstimated difference −0.9 percentage points 95% CI −4.4 to 2.6

Authors' conclusion

Among patients with sepsis-induced hypotension, the restrictive fluid strategy that was used in this trial did not result in significantly lower (or higher) mortality before discharge home by day 90 than the liberal fluid strategy.

Study context

Population
Patients with sepsis-induced hypotension refractory to initial 1 to 3 liters of intravenous fluid, randomised within 4 hours
Participants
1,563 patients
Comparison
Restrictive vs liberal fluid strategy for 24 h
  • Restrictive fluidn = 782
  • Liberal fluidn = 781reference
Primary endpoint
All-cause mortality before discharge home
Follow-up
Day 90
Methodological detailsunblinded, superiority, multicentre (60 US centers)
  • Unblinded
  • Superiority
  • Multicentre (60 US centers)

Primary result

As reported in the abstract

Estimated difference

−0.9 percentage points

95% CI −4.4 to 2.6

P = 0.61

Events by treatment group

Restrictive fluid vs Liberal fluid
estimated difference −0.9 percentage points (95% CI −4.4 to 2.6); P = 0.61

Further findings

OutcomeDifference of medians (ml) (95% CI)
Intravenous fluid volume during 24-h protocol period−2134 (−2318 to −1949)

Intravenous fluid volume during 24-h protocol period

Restrictive fluid group had earlier, more prevalent, and longer duration of vasopressor use

Safety

Number of reported serious adverse events similar in the two groups

Original publication

Early Restrictive or Liberal Fluid Management for Sepsis-Induced Hypotension. N Engl J Med. Published 21 January 2023. doi:10.1056/nejmoa2212663

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