Hypertonic Lactate After Cardiac Arrest (LATTE)

Free University of Brussels (ULB)

Status and phase: Enrolling; Phase 2

Conditions: Ischemia Reperfusion Injury; Cardiac Arrest; Anoxic Brain Injury

Treatments: Drug: Sodium Lactate Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05004610

SRB2021260

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 2 patient groups

standard of care

No Intervention group

Description:

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

treatement group

Experimental group

Description:

Sodium lactate infusion 15 µmol/Kg/min

Treatment:

Drug: Sodium Lactate Solution