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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05505396
Other study ID # P-2022-321
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 24, 2022
Est. completion date October 30, 2024

Study information

Verified date May 2024
Source Rigshospitalet, Denmark
Contact Alexandra Vassilieva
Phone +4526525373
Email alexandra.vassilieva@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 875
Est. completion date October 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
Sampling 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.

Locations

Country Name City State
Denmark Department of Neuroanesthesiology and Neurointensive Care, Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 All-cause mortality at 6 months (dichotomous). 6 months after admission.
Secondary Length of stay in the neuro-ICU (continuous). Day of discharge, typically 1-30 days after admission.
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