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

Acute Brain Injury Clinical Trial

— CLAMP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06393049
• Other study ID #: 23072860
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 8, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: Anne-Sophie Worm Fenger, MD
• Phone: +4524624359
• Email: anne-sophie.fenger.03[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 14
• Est. completion date: December 31, 2026
• Est. primary completion date: October 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Brain Injury
• Brain Injuries
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mathematic model of transport of glucose over the blood brain barrier.	Mathematic model of transport of glucose over the blood brain barrier.	Throughout the intervention, approximately five hours.
Primary	(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	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)	Throughout the intervention, approximately five hours
Secondary	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.	Throughout the intervention, approximately five hours.