An automated surface temperature management device effectively reduced fever burden among patients with acute vascular brain injury, but did not improve functional outcomes, according to results published in JAMA.

Researchers conducted an open-label randomized clinical trial with blinded outcome assessment (INTREPID; ClinicalTrials.gov Identifier: NCT02996266) between March 2017 and April 2020 to assess the effectiveness of an automated surface temperature management device (ArcticSun Temperature Management System) in the prevention of fever in patients with acute vascular brain injury and determine whether the device vs standard fever care improves functional outcomes. Critically ill patients with stroke at 43 intensive care units (ICUs) in 7 countries were randomly assigned 1:1 to receive fever prevention or standard care. In the fever prevention group, the target temperature was 37.0oC for 14 days or until ICU discharge. Fever was defined as a temperature of at least 38oC. The primary outcome was daily mean fever burden (oC-hour) through day 14 or until ICU discharge. Fever burden was calculated as the area under the temperature curve over 37.9°C divided by the number of hours in the acute phase multiplied by 24 hours. The principal secondary outcome global disability at day 90 by modified Rankin Scale (mRS) score, with a good outcome defined as an mRS score of 0 to 3.

Fever prevention in patients with acute vascular brain injury using an automated surface temperature management device reduced fever burden but did not improve functional outcomes.”

A total of 677 patients comprised the primary analysis population, of whom 339 (mean age, 61; women, 52.2%; White, 60.2%; ischemic stroke, 37.8%) were randomly assigned to fever prevention and 338 (mean age, 60.4; men, 50.3%; White, 55.9%; ischemic stroke, 37.3%) to standard care.

Overall, daily mean fever burden was lower in the fever prevention (0.37oC-hour) vs standard care (0.73oC-hour) group (risk difference, -0.35; 95% CI, -0.51 to -0.20; P <.001).

By stroke subtype, daily mean fever burden was also lower in the fever prevention vs standard care group for the following subtypes:

  • Ischemic stroke: 0.37oC-hour vs 0.47oC-hour (difference, -0.10oC-hour; 95% CI, -0.35 to 0.15);
  • Intracerebral hemorrhage: 0.29oC-hour vs 0.79oC-hour (difference, -0.50oC-hour; 95% CI, -0.78 to -0.22); and,
  • Subarachnoid hemorrhage: 0.47oC-hour vs 0.99oC-hour (difference, -0.52oC-hour; 95% CI, -0.81 to -0.23).

Positive fever burden was lower in the fever prevention vs standard care group for ischemic stroke (relative risk [RR], 0.69; 95% CI, 0.54-0.88; P <.001), intracerebral hemorrhage (RR, 0.70; 95% CI, 0.57-0.85; P <.001), and subarachnoid hemorrhage (RR, 0.79; 95% CI, 0.68-0.93; P <.001) in a supportive analysis.

At 3 months, the median mRS was 4.0 for both cohorts (odds ratio [OR] for a favorable shift in functional outcome, 1.09; 95% CI, 0.81-1.46; P =.54). A good outcome was achieved by 39.2% and 42.8% of participants in the intervention and standard care cohorts, respectively (RR, 0.92; 95% CI, 0.76-1.12).

Study limitations include the variation in standard care across regions and centers, lack of clinician blinding, and reduced generalizability of results to sites with poorer expertise in ICU treatment of patients with stroke and targeted temperature management.

“Fever prevention in patients with acute vascular brain injury using an automated surface temperature management device reduced fever burden but did not improve functional outcomes,” the study authors concluded.

Disclosure: This research was supported by Becton, Dickinson and Company. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.