Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury

Hyperglycemia Clinical Trial

— BRAIN-GLULAC  

Official title:

Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury in the Intensive Care Unit - a Prospective, Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505396
• Other study ID #: P-2022-321
• Status: Recruiting
• Start date: October 24, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2024
• Source: Rigshospitalet, Denmark
• Contact: Alexandra Vassilieva
• Phone: +4526525373
• Email: alexandra.vassilieva[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study of patients with severe acute brain injury, which aims to characterize the development of hyperglycaemia and hyperlactataemia and the influence of these markers on clinical outcome. Additionally, in a subgroup of patients undergoing advanced multimodal neuromonitoring on either clinical or research indication, the relationship between hyperglycaemia and brain glucose levels as well as systemic and microdialysis lactate will be examined.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 875
• Est. completion date: October 30, 2024
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Admission to the neurointensive care unit at Rigshospitalet
• Diagnosis of acute brain injury categorised as TBI, SAH, ICH, ischaemic stroke, or other conditions

Exclusion Criteria:

• Brain death before inclusion
• Closest relatives do not understand written and spoken Danish or English

Related Conditions & MeSH terms

• Acute Brain Injury
• Brain Injuries
• Hyperglycemia
• Hyperlactatemia
• Wounds and Injuries

Intervention

Other:
• Sampling of blood and cerebrospinal fluid
Blood HbA1c, insulin, C-peptide and IL-6 measured at admission. Glucose and lactate measured every 4 hours during intensive care stay. Daily sampling of CSV analysed for glucose and lactate in patients with EVD.

Locations

Country	Name	City	State
Denmark	Department of Neuroanesthesiology and Neurointensive Care, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome at 6 months as evaluated by the modified Rankin Scale.	Modified Rankin Scale ranges from 0-6, where 0 is the best and 6 is the worst outcome.	6 months after admission.
Secondary	All-cause mortality at 6 months (dichotomous).		6 months after admission.
Secondary	Length of stay in the neuro-ICU (continuous).		Day of discharge, typically 1-30 days after admission.