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

NCT ID: NCT06393049

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyperglycaemic clamp

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.

Group Type: OTHER

Hyperglycaemic clamp

Intervention Type: 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.

Interventions

Hyperglycaemic clamp

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Anne-Sophie Worm Fenger

Principal investigator, MD, PhD fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neuroanaesthesiology, Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Anne-Sophie Worm Fenger, MD

Role: CONTACT

anne-sophie.fenger.03@regionh.dk

+4524624359

Kirsten Møller, MD, PHD, DSC

Role: CONTACT

kirsten.moller@dadlnet.dk

35451616

Facility Contacts

Kirsten Møller, MD, PhD, DMSc, EDIC

Role: primary

kirsten.moeller.01@regionh.dk

004535451616

Anne-Sophie Worm Fenger, MD

Role: primary

anne-sophie.fenger.03@regionh.dk

+4524624359

Other Identifiers

23072860

Identifier Type: -

Identifier Source: org_study_id