Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Hypertonic Lactate After Cardiac Arrest

ID
Name
SRB2021260
Description
The study is intended to test the hypothesis that sodium lactate infusion after resuscitation from a cardiac arrest will decrease the magnitude of brain damage, as measured by the serum biomarker concentration of NSE.
Trial arms
Trial start
2024-10-01
Estimated PCD
2025-12-31
Trial end
2026-05-15
Status
Not yet recruiting
Phase
Early phase I
Treatment
Sodium Lactate Solution
continuous intravenous infusion of half-molar sodium lactate
Arms:
treatement group
Other names:
Hyperonic sodium lactate
Size
125
Primary endpoint
serum NSE
48 hours after randomization
Eligibility criteria
Inclusion Criteria: * Age \> 18 years old * Sustained (\> 20 minutes) return of spontaneous circulation (ROSC) * Comatose (GCS \< 9) * Time to ROSC \> 15' Exclusion Criteria: * Protected categories (Pregnant women, Prisoners) * Anticipated withdrawal of support within 24 hours * Traumatic cause of cardiac arrest * time from ROSC to inclusion \> 1hour * Inclusion in any other interventional trial
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 125, 'type': 'ESTIMATED'}}
Updated at
2024-02-20

1 organization

1 product

3 indications

Organization
Erasme University Hospital
Product
Sodium Lactate
Indication
Cardiac Arrest
Indication
Ischemia Reperfusion Injury
Indication
Anoxic Brain Injury