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

NCT06393049 | Completed

• 1 other identifier: 23072860
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

Acute brain injury; Intensive care; Neurointensive care; Anaesthesiology; Multimodal neuromonitoring; Glucose; Hyperglycaemic clamp

Outcome Measures

Primary Outcomes (1)

• (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)

  Throughout the intervention, approximately five hours

Secondary Outcomes (2)

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

  Throughout the intervention, approximately five hours

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

  Throughout the intervention, approximately five hours.

Other Outcomes (1)

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

  Throughout the intervention, approximately five hours.

Study Arms (1)

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.

Other: Hyperglycaemic clamp

Interventions

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.

Hyperglycaemic clamp

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (2)

Department of Neuroanaesthesiology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, PhD fellow

Model Details: 14 patients, all will have an hyperglycaemic clamp performed during admission while measuring cerebral microdialysis

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 1, 2024
• Study Start: May 8, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)