Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury

Recruiting

• Conditions: Hyperglycemia; Acute Brain Injury; Hyperlactatemia

• Registration Number: NCT05505396
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-17
• Study Start: 2022-10-24
• Primary Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 875

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional outcome at 6 months as evaluated by the modified Rankin Scale.	6 months after admission.	Modified Rankin Scale ranges from 0-6, where 0 is the best and 6 is the worst outcome.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality at 6 months (dichotomous).	6 months after admission.
Length of stay in the neuro-ICU (continuous).	Day of discharge, typically 1-30 days after admission.

Trial Locations

Locations (1)

Department of Neuroanesthesiology and Neurointensive Care, Rigshospitalet; 🇩🇰 Copenhagen, Denmark