Hypertonic Lactate After Cardiac Arrest

NCT05004610 | Recruiting Phase 2 DMC

• 1 other identifier: SRB2021260
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest; Ischemia Reperfusion Injury; Anoxic Brain Injury

Keywords

sodium lactate; cerebral metabolism

Outcome Measures

Primary Outcomes (1)

• serum NSE

  NSE serum levels

  48 hours after randomization

Secondary Outcomes (15)

• ICU length of stay

  trough study completion, on average 30 days

• Mortality

  trough study completion before hospital discharge, on average 90 days

• Neurological outcome

  trough study completion, 90 days after randomization

• Hospital length of stay

  trough study completion, on average 60 days

• Vasopressors equivalent dose

  through study completion, during the first 48 hours after resuscitation

Study Arms (2)

standard of care

NO INTERVENTION

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

treatement group

EXPERIMENTAL

Sodium lactate infusion 15 µmol/Kg/min

Drug: Sodium Lactate Solution

Interventions

Sodium Lactate Solution DRUG

continuous intravenous infusion of molar sodium lactate

Also known as: Hyperonic sodium lactate

treatement group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Sustained (\> 20 minutes) return of spontaneous circulation (ROSC)
• Comatose (GCS \< 9)
• Time to ROSC \> 15'

You may not qualify if:

• Protected categories (Pregnant women)
• Anticipated withdrawal of support within 24 hours
• Traumatic cause of cardiac arrest
• Body weight at admission \> 120Kg

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme Hospital, Brussels University Hospital (HUB)

Brussels, Belgium, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Reperfusion Injury; Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Filippo Annoni, MD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filippo Annoni, MD

CONTACT

0483141483; filippo.annoni@erasme.ulb.ac.be

Fabio S Taccone, MD,PhD

CONTACT

fabio.tacconei@erasme.ulb.ac.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 13, 2021
• Study Start: February 19, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 15, 2028
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)