Acute Brain InjuryCLAMPNCT06393049
Microdialysis and Jugular Bulb Glucose Profiles During Hyperglycaemic Clamping in Patients With Severe Acute Brain Injury
A study testing Hyperglycaemic clamp in people with Acute Brain Injury, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
Acute brain injury is a serious condition that often results in admission to an intensive care unit. Some of the most seriously ill patients are fitted with multimodal neuromonitoring, a newer monitoring modality that can, among other things, measure oxygen tension and sugar levels in brain tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury
- What is being tested?
- Hyperglycaemic clamp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesDenmark
- Study dates
- 8 May 2024to 31 Dec 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Admission to the neuro-ICU at Rigshospitalet.
- Multimodal neuromonitoring
Who cannot join
- Closest relative does not understand written and spoken Danish or English.
- Patients with known diabetes mellitus upon admission.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Neuroanaesthesiology, Rigshospitalet
Copenhagen, 2100
Rigshospitalet
Copenhagen, 2100
About this study
Acute brain injury is a serious condition that often results in admission to an intensive care unit. Some of the most seriously ill patients are fitted with multimodal neuromonitoring, a newer monitoring modality that can, among other things, measure oxygen tension and sugar levels in brain tissue. It is common clinical practice, but the interaction between the body's sugar levels and the brain's sugar levels is not sufficiently elucidated.
The study will investigate the relationship between the body's sugar levels, measured in arterial and venous blood, and the brain's sugar level, measured by microdialysis, in patients with severe acute brain injury.
Furthermore, we hope to be able to use our measurements to set up a mathematical model for the brain's sugar uptake.
- Conditions
- Acute Brain Injury
- Being tested
- Hyperglycaemic clamp
- Keywords
- Acute brain injury, Intensive care, Neurointensive care, Anaesthesiology, Multimodal neuromonitoring, Glucose, Hyperglycaemic clamp
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperglycaemic clampOther
Following an overnight fast, the investigators will perform simultaneous samples from the arterial line, the venous line, and microdialysis and consider these samples as baseline values.
If the patient's blood glucose level is at 8-10 mmol/L at baseline, the investigators will not proceed with the intervention and instead evaluate if the intervention can take place the following day.
After baseline values are measured, intravenous glucose 20% (200g/1,000 ml) is infused to raise the glucose levels in both plasma and extravascular glucose compartments with approximately 3 mmol/L.
| Study group | Role | What they receive |
|---|---|---|
| Hyperglycaemic clamp | Other | The purpose of hyperglycaemic clamping is to raise the blood glucose level to a fixed plateau and maintain the plateau for at least one hour to observe a steady-state blood glucose concentration.
The investigators intend to perform the hyperglycaemic clamping procedure one time in all 14 patients following an overnight fast and aim for a fixed blood glucose level above 8 mmol/L.
The patient will have an arterial line placed in the radial artery, a retrograde catheterization of the jugular bulb and a venous line for infusions of glucose, potassium, and isotonic saline.
To maintain potassium levels at wanted levels, an isotonic saline solution containing potassium will be infused continuously and arterial samples of potassium and glucose will be measured at minimum every 10 minutes from the start of the intervention. Receives: Other: Hyperglycaemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Change in) MD-glucose (mmol/L)
Change in) MD-glucose (mmol/L) over time as a function of (a set change in) arterial blood glucose (mmol/L)
Measured: Throughout the intervention, approximately five hours
Secondary outcomes (2)
Jugular vein glucose (mmol/L) over time as a function of arterial blood glucose.
Jugular vein glucose (mmol/L) over time as a function of arterial blood glucose (mmol/L)
Measured: Throughout the intervention, approximately five hours
Lactate-pyruvate-ratio (LP-ratio) as a function of arterial blood glucose.
Two other microdialysis paramethers, lactate and pyruvat, will be assessed to evaluate the lactate-pyruvate ratio over time as a function of arteriel blood glucose.
Measured: Throughout the intervention, approximately five hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start8 May 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 14 patients, all will have an hyperglycaemic clamp performed during admission while measuring cerebral microdialysis
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Sophie Worm Fenger, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393049
- Sponsor's protocol ID
- 23072860
- Acronym
- CLAMP
- Status last verified
- Feb 2026
- First submitted
- 25 Apr 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microdialysis and Jugular Bulb Glucose Profiles During Hyperglycaemic Clamping in Patients With Severe Acute Brain Injury
- ClinicalTrials.gov ID
- NCT06393049
- Acronym / sponsor ID
- CLAMP / 23072860
- Conditions
- Acute Brain Injury
- Keywords
- Acute brain injury, Intensive care, Neurointensive care, Anaesthesiology, Multimodal neuromonitoring, Glucose, Hyperglycaemic clamp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 May 2024 (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.
Acute brain injury is a serious condition that often results in admission to an intensive care unit. Some of the most seriously ill patients are fitted with multimodal neuromonitoring, a newer monitoring modality that can, among other things, measure oxygen tension and sugar levels in brain tissue. It is common clinical practice, but the interaction between the body's sugar levels and the brain's sugar levels is not sufficiently elucidated.
The study will investigate the relationship between the body's sugar levels, measured in arterial and venous blood, and the brain's sugar level, measured by microdialysis, in patients with severe acute brain injury.
Furthermore, we hope to be able to use our measurements to set up a mathematical model for the brain's sugar uptake.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 14 patients, all will have an hyperglycaemic clamp performed during admission while measuring cerebral microdialysis
| Arm | Type | Receives |
|---|---|---|
| Hyperglycaemic clamp | Other | Other: Hyperglycaemic clampThe purpose of hyperglycaemic clamping is to raise the blood glucose level to a fixed plateau and maintain the plateau for at least one hour to observe a steady-state blood glucose concentration. The investigators intend to perform the hyperglycaemic clamping procedure one time in all 14 patients following an overnight fast and aim for a fixed blood glucose level above 8 mmol/L. The patient will have an arterial line placed in the radial artery, a retrograde catheterization of the jugular bulb and a venous line for infusions of glucose, potassium, and isotonic saline. To maintain potassium levels at wanted levels, an isotonic saline solution containing potassium will be infused continuously and arterial samples of potassium and glucose will be measured at minimum every 10 minutes from the start of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Admission to the neuro-ICU at Rigshospitalet.
- Multimodal neuromonitoring
Key exclusion criteria (2 listed)
- Closest relative does not understand written and spoken Danish or English.
- Patients with known diabetes mellitus upon admission.
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 |
|---|---|---|
| Hyperglycaemic clampFollowing an overnight fast, the investigators will perform simultaneous samples from the arterial line, the venous line, and microdialysis and consider these samples as baseline values. If the patient's blood glucose level is at 8-10 mmol/L at baseline, the investigators will not proceed with the intervention and instead evaluate if the intervention can take place the following day. After baseline values are measured, intravenous glucose 20% (200g/1,000 ml) is infused to raise the glucose levels in both plasma and extravascular glucose compartments with approximately 3 mmol/L. | Other | Hyperglycaemic clamp |
Primary outcome
(Change in) MD-glucose (mmol/L)
Time frame: Throughout the intervention, approximately five hours
Change in) MD-glucose (mmol/L) over time as a function of (a set change in) arterial blood glucose (mmol/L)
2 secondary outcomes
Jugular vein glucose (mmol/L) over time as a function of arterial blood glucose.
Time frame: Throughout the intervention, approximately five hours
Lactate-pyruvate-ratio (LP-ratio) as a function of arterial blood glucose.
Time frame: Throughout the intervention, approximately five hours.
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 25 Feb 2026.
- Individual participant dataSharing planned: No
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Fareon Open Label Device Clinical Trial
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperglycaemic clamp in people with Acute Brain Injury, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
(Change in) MD-glucose (mmol/L) (time frame: Throughout the intervention, approximately five hours). 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 25 Feb 2026.