Neuroanesthesia & neurocritical care

Fever Prevention in Patients With Acute Vascular Brain Injury: The INTREPID Randomized Clinical Trial

JAMAPublished Randomised controlled trial

Primary resultResult — go to the resultDifference −0.35 95% CI −0.51 to −0.20
  • Enrolled 686 of 1176 planned patients; stopped early after planned interim analysis demonstrated futility of the principal secondary end point

Authors' conclusion

In patients with acute vascular brain injury, preventive normothermia using an automated surface temperature management device effectively reduced fever burden but did not improve functional outcomes.

Study context

Population
Critically ill patients with stroke (ischemic stroke, intracerebral hemorrhage, SAH)primary analysis population
Participants
677 patients
Comparison
Fever prevention vs standard care
  • Fever preventionn = 339
  • Standard caren = 338reference
Primary endpoint
Daily mean fever burden (area under the temperature curve above 37.9 °C divided by hours in the acute phase, ×24; °C-hour)
Methodological detailsopen-label, blinded outcome assessment, multicentre (43 ICUs, 7 countries), planned interim analysis, 433 (64%) completed the study through 12 months
  • Open-label
  • Blinded outcome assessment
  • Multicentre (43 ICUs, 7 countries)
  • Planned interim analysis
  • 433 (64%) completed the study through 12 months

Primary result

As reported in the abstract

Difference

−0.35

95% CI −0.51 to −0.20

P < 0.001

By group

Fever prevention vs Standard care
difference −0.35 (95% CI −0.51 to −0.20); P < 0.001

Secondary outcomes

Daily mean fever burden by stroke subtype (subgroup)

Between-group difference, ischemic stroke
−0.10 (95% CI, −0.35 to 0.15)
Between-group difference, intracerebral hemorrhage
−0.50 (95% CI, −0.78 to −0.22)
Between-group difference, SAH
−0.52 (95% CI, −0.81 to −0.23)
  • All P < .001 by Wilcoxon rank-sum test

Functional recovery (shift analysis of modified Rankin Scale, principal secondary outcome) · 3 months

OR for a favorable shift in functional outcome (95% CI, 0.81 to 1.46; P = .54); no significant difference
1.09
  • Enrollment stopped after planned interim analysis demonstrated futility of the principal secondary end point

Safety

Major adverse events

Infections

Cardiac disorders

Respiratory disorders

Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.

Original publication

Fever Prevention in Patients With Acute Vascular Brain Injury: The INTREPID Randomized Clinical Trial. JAMA. Published 12 November 2024. doi:10.1001/jama.2024.14745

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