Neuroanesthesia & neurocritical care
Fever Prevention in Patients With Acute Vascular Brain Injury: The INTREPID Randomized Clinical 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
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
Composed by AI from the published abstract and checked against it. How Briefs are made →