Acute Brain InjuryBRAIN-GLULACNCT05505396
Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury
An observational study of Acute Brain Injury and Hyperglycemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This is an observational study of patients with severe acute brain injury, which aims to characterize the development of hyperglycaemia and hyperlactataemia and the influence of these markers on clinical outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury, Hyperglycemia, Hyperlactatemia
- What is being tested?
- Sampling of blood and cerebrospinal fluid
- How many people
- 459 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Oct 2022to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: The study will include all patients with severe acute brain injury, admitted to the neuro intensive care department at Rigshospitalet, Denmark. Mainly, it will be patients with TBI, SAH, ICH or acute ischaemic stroke.
Who may be able to join
- Age ≥ 18 years
- Admission to the neurointensive care unit at Rigshospitalet
- Diagnosis of acute brain injury categorised as TBI, SAH, ICH, ischaemic stroke, or other conditions
Who cannot join
- Brain death before inclusion
- Closest relatives do not understand written and spoken Danish or English
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Neuroanesthesiology and Neurointensive Care, Rigshospitalet
Copenhagen
About this study
Official title: Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury in the Intensive Care Unit - a Prospective, Observational Cohort Study
This is an observational study of patients with severe acute brain injury, which aims to characterize the development of hyperglycaemia and hyperlactataemia and the influence of these markers on clinical outcome.
Additionally, in a subgroup of patients undergoing advanced multimodal neuromonitoring on either clinical or research indication, the relationship between hyperglycaemia and brain glucose levels as well as systemic and microdialysis lactate will be examined.
- Conditions
- Acute Brain Injury, Hyperglycemia, Hyperlactatemia
- Being tested
- Sampling of blood and cerebrospinal fluid
- Medical subject headings
- Brain Injuries, Hyperglycemia, Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of blood and cerebrospinal fluidOther
Blood HbA1c, insulin, C-peptide and IL-6 measured at admission. Glucose and lactate measured every 4 hours during intensive care stay. Daily sampling of CSV analysed for glucose and lactate in patients with EVD.
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome at 6 months as evaluated by the modified Rankin Scale.
Modified Rankin Scale ranges from 0-6, where 0 is the best and 6 is the worst outcome.
Measured: 6 months after admission.
Secondary outcomes (2)
All-cause mortality at 6 months (dichotomous).
Measured: 6 months after admission.
Length of stay in the neuro-ICU (continuous).
Measured: Day of discharge, typically 1-30 days after admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start24 Oct 2022
- Primary completion30 Apr 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Vassilieva, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505396
- Sponsor's protocol ID
- P-2022-321
- Acronym
- BRAIN-GLULAC
- Status last verified
- Jul 2025
- First submitted
- 16 Aug 2022
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will only be shared with a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury in the Intensive Care Unit - a Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05505396
- Acronym / sponsor ID
- BRAIN-GLULAC / P-2022-321
- Conditions
- Acute Brain Injury, Hyperglycemia, Hyperlactatemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 17 Aug 2022 (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.
This is an observational study of patients with severe acute brain injury, which aims to characterize the development of hyperglycaemia and hyperlactataemia and the influence of these markers on clinical outcome.
Additionally, in a subgroup of patients undergoing advanced multimodal neuromonitoring on either clinical or research indication, the relationship between hyperglycaemia and brain glucose levels as well as systemic and microdialysis lactate will be examined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will include all patients with severe acute brain injury, admitted to the neuro intensive care department at Rigshospitalet, Denmark. Mainly, it will be patients with TBI, SAH, ICH or acute ischaemic stroke.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Admission to the neurointensive care unit at Rigshospitalet
- Diagnosis of acute brain injury categorised as TBI, SAH, ICH, ischaemic stroke, or other conditions
Key exclusion criteria (2 listed)
- Brain death before inclusion
- Closest relatives do not understand written and spoken Danish or English
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 |
|---|---|---|
| Sampling of blood and cerebrospinal fluidBlood HbA1c, insulin, C-peptide and IL-6 measured at admission. Glucose and lactate measured every 4 hours during intensive care stay. Daily sampling of CSV analysed for glucose and lactate in patients with EVD. | Other | – |
Primary outcome
Functional outcome at 6 months as evaluated by the modified Rankin Scale.
Time frame: 6 months after admission.
Modified Rankin Scale ranges from 0-6, where 0 is the best and 6 is the worst outcome.
2 secondary outcomes
All-cause mortality at 6 months (dichotomous).
Time frame: 6 months after admission.
Length of stay in the neuro-ICU (continuous).
Time frame: Day of discharge, typically 1-30 days after admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Undecided. IPD will only be shared with a data sharing agreement.
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Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
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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?
An observational study of Acute Brain Injury and Hyperglycemia, run by Copenhagen University Hospital, Rigshospitalet 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: finished, as of the sponsor's last update on 29 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional outcome at 6 months as evaluated by the modified Rankin Scale. (time frame: 6 months after admission.). 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 29 Jul 2025.