Status:
NOT_YET_RECRUITING
Sodium Lactate Versus Hypertonic Saline Solution in the Treatment of Intracranial Hypertensive Episodes in Severe Brain Injured Patients
Lead Sponsor:
University Hospital, Geneva
Conditions:
Intra Cerebral Hypertension
Lactate Sodium Solution
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Brain oedema is a major complication of brain injury (TBI). It increases the risk of intracranial hypertension (ICH) and brain hypoxia, leading to an increase in mortality and poor neurologic outcome....
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patient with an acute, isolated, severe brain injury (SAH, TBI, ICH)
- Glasgow coma score \<8
- Monitored using ICP device
- Presenting an episode of intracranial hypertension requiring osmotherapy. ( defined as increase in ICP 25 mmHg which persisted for more than 5 min in the absence of noxious stimulations)
- Informed Consent as documented by signature
- Exclusion criteria
- Pregnant woman
- Bilateral fixed dilatated pupils
- Initial hypernatremia (\>155 mmol/l)
- Penetrating head injury
- Active participation to another trial (Clin B, C)
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06110429
Start Date
January 1 2024
End Date
January 1 2026
Last Update
October 31 2023
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