FeverNCT07709325
Permissive Hyperthermia in Acute Brain Injury
A study testing Temperature < 39,5 and Temperature <37.5 in people with Fever, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fever
- What is being tested?
- Temperature < 39,5 and Temperature <37.5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Apr 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe acute brain injury.
- Requirement for:
- Mechanical ventilation Sedation Intracranial pressure (ICP) monitoring
Who cannot join
- Pregnancy
- Moribund patients or patients in whom withdrawal of active treatment is anticipated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fever
- Being tested
- Temperature < 39,5, Temperature <37.5
- Keywords
- permissive hyperthermia
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature < 39,5Other
Also called fever
Allowing temperature up to 39,5 in patients with acute brain injury
Temperature <37.5Other
Also called no fever
Standard care of temperature
| Study group | Role | What they receive |
|---|---|---|
| Permissive hyperthermia | Experimental | Permissive hyperthermia allowed up to 39.5°C before intervention Receives: Other: Temperature < 39,5 |
| Standard temperature control | Active comparator | Normothermia actively maintained per current standard Receives: Other: Temperature <37.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days from enrollment, or until multi-bolt has been removed, or the patients had died
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start25 Apr 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josefine Thomsen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709325
- Sponsor's protocol ID
- OP_2717
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study to small
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permissive Hyperthermia in Traumatic Brain Injury and Acute Vascular Brain Injury
- ClinicalTrials.gov ID
- NCT07709325
- Acronym / sponsor ID
- OP_2717
- Conditions
- Fever
- Keywords
- permissive hyperthermia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 25 Apr 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Permissive hyperthermia | Experimental | Other: Temperature < 39,5Permissive hyperthermia allowed up to 39.5°C before intervention |
| Standard temperature control | Active comparator | Other: Temperature <37.5Normothermia actively maintained per current standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe acute brain injury.
- Requirement for:
- Mechanical ventilation Sedation Intracranial pressure (ICP) monitoring
Key exclusion criteria (2 listed)
- Pregnancy
- Moribund patients or patients in whom withdrawal of active treatment is anticipated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temperature < 39,5Also: feverAllowing temperature up to 39,5 in patients with acute brain injury | Other | Permissive hyperthermia |
| Temperature <37.5Also: no feverStandard care of temperature | Other | Standard temperature control |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No. The study to small
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temperature < 39,5 and Temperature <37.5 in people with Fever, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.