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

Not Applicable

Recruiting

• Conditions: Acute Brain Injury
• Interventions: Other: Hyperglycaemic clamp

• Registration Number: NCT06393049
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-01
• Study Start: 2024-05-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-10-08
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperglycaemic clamp	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.

Primary Outcome Measures

Name	Time	Method
(Change in) MD-glucose (mmol/L)	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 Outcome Measures

Name	Time	Method
Jugular vein glucose (mmol/L) over time as a function of arterial blood glucose.	Throughout the intervention, approximately five hours	Jugular vein glucose (mmol/L) over time as a function of arterial blood glucose (mmol/L)
Lactate-pyruvate-ratio (LP-ratio) as a function of arterial blood glucose.	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.

Trial Locations

Locations (2)

Department of Neuroanaesthesiology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark