Hypertonic Lactate After Cardiac Arrest

NCT ID: NCT05004610

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-19
• Study Completion Date: 2028-05-15

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.

Conditions

Cardiac Arrest; Ischemia Reperfusion Injury; Anoxic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard of care

Patients will receive the standard of care infusion (balanced crystalloids)

Group Type: NO_INTERVENTION

No interventions assigned to this group

treatement group

Sodium lactate infusion 15 µmol/Kg/min

Group Type: EXPERIMENTAL

Sodium Lactate Solution

Intervention Type: DRUG

continuous intravenous infusion of molar sodium lactate

Interventions

Sodium Lactate Solution

continuous intravenous infusion of molar sodium lactate

Intervention Type: DRUG

Other Intervention Names

Hyperonic sodium lactate

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Filippo Annoni, MD

Role: PRINCIPAL_INVESTIGATOR

H.U.B Erasme

Locations

Erasme Hospital, Brussels University Hospital (HUB)

Brussels, Belgium, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Filippo Annoni, MD

Role: CONTACT

filippo.annoni@erasme.ulb.ac.be

0483141483

Fabio S Taccone, MD,PhD

Role: CONTACT

fabio.tacconei@erasme.ulb.ac.be

Other Identifiers

SRB2021260

Identifier Type: -

Identifier Source: org_study_id