Last updated: October 30, 2023
Sponsor: University Hospital, Geneva
Overall Status: Active - Not Recruiting
Phase
3
Condition
Williams Syndrome
Stress
Vascular Diseases
Treatment
Hypertonic saline
Lactate, Sodium
Clinical Study ID
NCT06110429
701546
Ages 18-65 All Genders
Study Summary
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)
Study Design
Total Participants: 52
Treatment Group(s): 2
Primary Treatment: Hypertonic saline
Phase: 3
Study Start date:
January 01, 2024
Estimated Completion Date:
January 31, 2026