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Completed

NCT Number: NCT05505396

Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neuroanesthesiology and Neurointensive Care, Rigshospitalet

Copenhagen, Denmark

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Functional outcome at 6 months as evaluated by the modified Rankin Scale.

    Time frame: 6 months after admission.

    Modified Rankin Scale ranges from 0-6, where 0 is the best and 6 is the worst outcome.

Secondary outcomes

  1. All-cause mortality at 6 months (dichotomous).

    Time frame: 6 months after admission.

  2. Length of stay in the neuro-ICU (continuous).

    Time frame: Day of discharge, typically 1-30 days after admission.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: BRAIN-GLULAC

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2022
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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