Continuous Hyperosomolar Therapy for Traumatic Brain-injured Patients
Status:
Completed
Trial end date:
2020-03-05
Target enrollment:
Participant gender:
Summary
Traumatic brain injury (TBI) is a major cause of death and severe prolonged disability.
Intracranial hypertension (ICH) is a critical risk factor of bad outcomes after TBI.
Continuous infusion of hyperosmolar therapy has been proposed for the prevention or the
treatment of ICH. Whether an early administration of continuous hyperosmolar therapy improves
long term outcomes is uncertain. The aim of the current study is to assess the efficiency and
the safety of continuous hyperosmolar therapy in TBI patients.
The COBI trial is the first randomized controlled trial powered to investigate whether
continuous hyperosmolar therapy in TBI patients improve long term recovery.
Hypothesis
Patients treated with early continuous hyperosmolar therapy have reduced morbidity and
mortality rates compared to those receiving standard care alone after traumatic brain injury.
Research Questions
1. Does early continuous hyperosmolar therapy reduce morbidity and mortality rates at 3 and
6 months after TBI assessed by the GOSE questionnaire?
2. Does early continuous hyperosmolar therapy prevent intracranial hypertension?