Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury

NCT05505396 | Completed DMC

• 1 other identifier: P-2022-321
• Study Type: observational
• Target: 459
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Brain Injury; Hyperglycemia; Hyperlactatemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Interventions

Sampling of blood and cerebrospinal fluid OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Closest relatives do not understand written and spoken Danish or English

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Neuroanesthesiology and Neurointensive Care, Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Brain Injuries; Hyperglycemia; Hyperlactatemia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: October 24, 2022
• Primary Completion: April 30, 2024
• Study Completion: October 30, 2024
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

DK (1)