Permissive Hyperthermia in Acute Brain Injury

NCT07709325 | Active Not Recruiting DMC

• 1 other identifier: OP_2717
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fever

Keywords

permissive hyperthermia

Outcome Measures

Primary Outcomes (1)

• Record numbers of episodes and the time frame when temperature needed to be lowered to maintain acceptable intracranial pressure.

  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

Study Arms (2)

Permissive hyperthermia

EXPERIMENTAL

Permissive hyperthermia allowed up to 39.5°C before intervention

Other: Temperature < 39,5

Standard temperature control

ACTIVE COMPARATOR

Normothermia actively maintained per current standard

Other: Temperature <37.5

Interventions

Temperature < 39,5 OTHER

Allowing temperature up to 39,5 in patients with acute brain injury

Also known as: fever

Permissive hyperthermia

Temperature <37.5 OTHER

Standard care of temperature

Also known as: no fever

Standard temperature control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe acute brain injury.
• Requirement for:
• Mechanical ventilation Sedation Intracranial pressure (ICP) monitoring

You may not qualify if:

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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Neurointensiv care

Odense C, 5000, Denmark

Location

MeSH Terms

Conditions

Fever

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 16, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)