Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury (BRAIN-GLULAC)

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Acute Brain Injury; Hyperlactatemia
• Intervention / Treatment: Other: Sampling of blood and cerebrospinal fluid

• Study Type: Observational
• Enrollment (Actual): 459

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Department of Neuroanesthesiology and Neurointensive Care, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The study will include all patients with severe acute brain injury, admitted to the neuro intensive care department at Rigshospitalet, Denmark. Mainly, it will be patients with TBI, SAH, ICH or acute ischaemic stroke.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Hyperglycemia; Hyperlactatemia
• Other Study ID Numbers: P-2022-321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will only be shared with a data sharing agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No