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NCT Number: NCT06393049

Microdialysis and Jugular Bulb Glucose Profiles During Hyperglycaemic Clamping in Patients With Severe Acute Brain Injury

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.

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Key information

Conditions

Acute Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neuroanaesthesiology, Rigshospitalet, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Admission to the neuro-ICU at Rigshospitalet.
  • Multimodal neuromonitoring

Exclusion criteria

  • Closest relative does not understand written and spoken Danish or English.
  • Patients with known diabetes mellitus upon admission.

Treatment and study plan

Hyperglycaemic clamp

Other

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.

Primary outcomes

  1. (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)

Secondary outcomes

  1. Jugular vein glucose (mmol/L) over time as a function of arterial blood glucose.

    Time frame: Throughout the intervention, approximately five hours

    Jugular vein glucose (mmol/L) over time as a function of arterial blood glucose (mmol/L)

  2. Lactate-pyruvate-ratio (LP-ratio) as a function of arterial blood glucose.

    Time frame: Throughout the intervention, approximately five hours.

    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.

Other outcomes

  1. Mathematic model of transport of glucose over the blood brain barrier.

    Time frame: Throughout the intervention, approximately five hours.

    Mathematic model of transport of glucose over the blood brain barrier.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Acronym: CLAMP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 1, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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