Hypertonic Lactate After Cardiac Arrest (LATTE)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest; Ischemia Reperfusion Injury; Anoxic Brain Injury
• Intervention / Treatment: Drug: Sodium Lactate Solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Filippo Annoni, MD; Phone Number: 0483141483; Email: filippo.annoni@erasme.ulb.ac.be
• Study Contact Backup: Name: Fabio S Taccone, MD,PhD; Email: fabio.tacconei@erasme.ulb.ac.be

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Recruiting
    • Erasme Hospital, Brussels University Hospital (HUB)
    • Contact: Fabio Silvio Taccone, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard of care; Patients will receive the standard of care infusion (balanced crystalloids)
Experimental: treatement group; Sodium lactate infusion 15 µmol/Kg/min	Drug: Sodium Lactate Solution; continuous intravenous infusion of molar sodium lactate; Other Names: Hyperonic sodium lactate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum NSE	NSE serum levels	48 hours after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Hospital length of stay	trough study completion, on average 60 days
Severe adverse events rate	Serious adverse events rate	during study drug administration/day 28 or ICU discharge or death
Seizure rate	Seizure rate	through study completion before ICU discharge, on average 14 days
Changes in cardiac biomarkers	Troponin I serum levels	at randomization, 24 hours, 48 hours and 72 hours after randomization
Changes in brain biomarkers	brain biomarkers including nfL and GFAP	at randomization, after 24 hours, 48 hours and 72 hours
Changes in brain metabolism	Brain metabolism measured by PET-IRM	within 24h after randomization
Changes in brain perfusion	brain perfusion measured with early perfusion CT scan	within 24h after randomization
Changes in echocardiographic parameters (systolic)	Changes systolic cardiac function assessed by echocardiography	at randomization, at 24 hours and 48 hours after randomization
Changes in echocardiographic parameters (diastolic)	Changes diastolic cardiac function assessed by echocardiography	at randomization, at 24 hours and 48 hours after randomization
identification of optimal perfusion pressure	identification of optimal perfusion pressure with invasive neuromonitoring	through study completion, on average 30 days
identification of optimal cerebral oxygen tension	identification of optimal cerebral oxygen tension with invasive neuromonitoring	through study completion, on average 30 days
ICU length of stay	number of days in the intensive care unit	trough study completion, on average 30 days
Mortality	mortality	trough study completion before hospital discharge, on average 90 days
Neurological outcome	Neurological outcome measured by Cerebral Performance Category score at 90 days (1-5, 1 meaning better Neurological outcome)	trough study completion, 90 days after randomization
Vasopressors equivalent dose	Vasopressors equivalent dose during the first 48 hours after resuscitation	through study completion, during the first 48 hours after resuscitation

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Filippo Annoni, MD, Hopital Erasme

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 15, 2028

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: cerebral metabolism; sodium lactate
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Heart Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Heart Arrest; Reperfusion Injury
• Other Study ID Numbers: SRB2021260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD may be available on reasonable request to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No