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CompletedNCT05505396BRAIN-GLULACUpdated Jul 29, 2025

Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury

An observational study in Acute Brain Injury, Hyperglycemia and Hyperlactatemia, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-29.

Sponsored by Rigshospitalet, Denmark · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
459
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Brain Injuries by Rigshospitalet, Denmark — 5 open to participants now, 7 under way, none of them phase 3. Brain Injuries · Rigshospitalet, Denmark.

Enrollment
Largest of 13
459 · median 100
Started
2022
the only one that year
Observational
12 of 20
4 open now
Registered
11th of 20
by date

Among the 20 studies in Brain Injuries by Rigshospitalet, Denmark, this one has the largest enrollment of the 13 observational ones, is the only one that started in 2022, is one of 12 observational ones, and was the 11th registered.

By phase

20 studies; the count open now beside each. This study's row is marked.

Observationalthis study12 · 4 open
No phase6 · 1 open
Other kind2 · 0 open

By the year they started

First in 2003; this study’s year is marked. 1 started in 2022.

Size and results

Median enrollment 98 across the 6 interventional studies, 100 across the 13 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 20 studies in Brain Injuries by Rigshospitalet, Denmark, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Acute Brain Injury
  • Hyperglycemia
  • Hyperlactatemia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Brain death before inclusion
  • Closest relatives do not understand written and spoken Danish or English
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
459 participants (actual)
Patient registry
No

Interventions

  • OtherSampling 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.

06

What researchers measure

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.

    Time frame: 6 months after admission.

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.

07

Study locations

1 site
  • Department of Neuroanesthesiology and Neurointensive Care, Rigshospitalet
    Copenhagen, Denmark
08

References and documents

Individual participant data

Plan to share: Undecided — IPD will only be shared with a data sharing agreement.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05505396
Responsible party
Alexandra Vassilieva (Principal Investigator, Rigshospitalet, Denmark) — Principal investigator
First posted
Aug 17, 2022
Start date
Oct 24, 2022
Primary completion
Apr 30, 2024
Completion
Oct 30, 2024
Last update
Jul 29, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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