Permissive Hyperthermia in Acute Brain Injury

July 13, 2026 updated by: Josefine Thomsen, Odense University Hospital

Permissive Hyperthermia in Traumatic Brain Injury and Acute Vascular Brain Injury

The purpose of this pilot study is to find out whether it is possible to work together with the body's own reactions, where the temperature goes up (fever), in a safe and controlled way.

The main question to answer is:

Is it practical and safe to allow higher body temperature (up to 39.5°C) as part of the treatment for critically ill patients with brain injury?

Patients with acute brain injury will be Placed in one of two groups: one where fever is treated to keep the temperature below 37.5°C, and one where fever is allowed up to 39.5°C.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Background Fever is common in patients with acute brain injury and is routinely suppressed despite limited evidence from randomized trials demonstrating benefit. Observational studies associate hyperthermia with worse outcomes, but it remains unclear whether fever is causative or reflects injury severity. Experimental and clinical data suggest that temperature reduction may adversely affect cerebral perfusion pressure and brain tissue oxygenation. This pilot study evaluates the feasibility and safety of permissive hyperthermia compared with standard normothermic care in neurocritical patients with severe acute brain injury.

Methods The investigators conduct a prospective, randomized, open-label pilot study in a neurointensive care unit. Twenty adult patients with severe acute brain injury requiring mechanical ventilation, sedation, and intracranial pressure monitoring are randomized 1:1 to permissive hyperthermia or standard care. In the intervention group, fever is tolerated up to 39.5°C, whereas the control group receives active temperature control from 37.5°C according to current practice. All patients are monitored using a multimodal intracranial system enabling continuous intracranial pressure and brain tissue oxygen tension measurement, cerebral microdialysis, and transcranial Doppler ultrasonography. Primary outcome is feasibility, defined by the need for temperature-lowering interventions due to refractory intracranial hypertension. Secondary outcomes include intracranial pressure, cerebral perfusion pressure, brain tissue oxygenation, cerebral metabolism, vasopressor requirements, length of stay, and functional status.

Results This is an ongoing pilot study. Recruitment feasibility, protocol adherence, and safety outcomes will be reported. Interim safety analysis is planned after inclusion of 10 patients.

Conclusions This pilot study will provide essential feasibility and safety data on permissive hyperthermia in severe acute brain injury. The results will inform the design of a future multicenter study.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense C, Denmark, 5000
        • Neurointensiv care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Severe acute brain injury.
  • Requirement for:

Mechanical ventilation Sedation Intracranial pressure (ICP) monitoring

Exclusion Criteria:

  • Pregnancy
  • Moribund patients or patients in whom withdrawal of active treatment is anticipated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Permissive hyperthermia
Permissive hyperthermia allowed up to 39.5°C before intervention
Other: Temperature < 39,5
Allowing temperature up to 39,5 in patients with acute brain injury
Other Names:
  • fever
Active Comparator: Standard temperature control
Normothermia actively maintained per current standard
Other: Temperature <37.5
Standard care of temperature
Other Names:
  • no fever

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Record numbers of episodes and the time frame when temperature needed to be lowered to maintain acceptable intracranial pressure.
Time Frame: 14 days from enrollment, or until multi-bolt has been removed, or the patients had died
This only applies to patients included in the group, where temperatures up to 39.5°C are allowed
14 days from enrollment, or until multi-bolt has been removed, or the patients had died

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OP_2717

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study to small

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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