Clinical trial NCT05004610: Hypertonic Lactate After Cardiac Arrest
Official title: Hypertonic Lactate After Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cardiac Arrest
Ischemia Reperfusion Injury
Anoxic Brain Injury
Keywords: sodium lactate
cerebral metabolism
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Background: In resuscitated patients after cardiac arrest, ischemic brain injury and cardiac depression due to the reperfusion injury are accountable for high mortality rate and poor outcome. Hypertonic sodium lactate (HSL) solutions have been proven to be safe in healthy volunteers and they have shown some benefits in patients with traumatic brain injury and those with myocardial ischemia and could decrease the burden of hypoxic lesions in these organs. The aim of this phase II study is to investigate whether HSL administration could reduce organ damage related biomarkers in serum and if the administrations of these solutions is safe and feasible in resuscitated patients after cardiac arrest.

Design: an investigator initiated, randomized, controlled, open label phase II clinical trial to test the safety and efficacy of the infusion of HSL in resuscitated patients after cardiac arrest admitted to the hospital. After resuscitation from CA, comatose patients will be screened for eligibility and randomized to receive either study treatment as HSL 1M infusion for 24h or standard of care.

Expected outcomes: This controlled trial will assess the safety and efficacy of the 1M HSL infusion in a cohort of comatose resuscitated patients after cardiac arrest. The results of this trial may provide useful information for a larger phase III clinical trial.

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)
* Anticipated withdrawal of support within 24 hours
* Traumatic cause of cardiac arrest
* Body weight at admission \> 120Kg

Primary outcomes:
measure: serum NSE
timeFrame: 48 hours after randomization
Secondary outcomes:
measure: ICU length of stay
timeFrame: trough study completion, on average 30 days
measure: Mortality
timeFrame: trough study completion before hospital discharge, on average 90 days
measure: Neurological outcome
timeFrame: trough study completion, 90 days after randomization
measure: Hospital length of stay
timeFrame: trough study completion, on average 60 days
measure: Vasopressors equivalent dose
timeFrame: through study completion, during the first 48 hours after resuscitation
measure: Seizure rate
timeFrame: through study completion before ICU discharge, on average 14 days
measure: Changes in cardiac biomarkers
timeFrame: at randomization, 24 hours, 48 hours and 72 hours after randomization
measure: Changes in brain biomarkers
timeFrame: at randomization, after 24 hours, 48 hours and 72 hours
measure: Severe adverse events rate
timeFrame: during study drug administration/day 28 or ICU discharge or death
measure: Changes in brain metabolism
timeFrame: within 24h after randomization
measure: Changes in brain perfusion
timeFrame: within 24h after randomization
measure: Changes in echocardiographic parameters (systolic)
timeFrame: at randomization, at 24 hours and 48 hours after randomization
measure: Changes in echocardiographic parameters (diastolic)
timeFrame: at randomization, at 24 hours and 48 hours after randomization
measure: identification of optimal perfusion pressure
timeFrame: through study completion, on average 30 days
measure: identification of optimal cerebral oxygen tension
timeFrame: through study completion, on average 30 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital, Brussels University Hospital (HUB)
Study officials:
affiliation: Hôpital Erasme
name: Filippo Annoni, MD
role: PRINCIPAL_INVESTIGATOR
References: