Hypertonic Lactate After Cardiac Arrest

Cardiac Arrest Clinical Trial

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Official title:

Hypertonic Lactate After Cardiac Arrest

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05004610
• Other study ID #: SRB2021260
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2024
• Est. completion date: May 15, 2026

Study information

• Verified date: January 2024
• Source: Erasme University Hospital
• Contact: Filippo Annoni, MD
• Phone: 0483141483
• Email: filippo.annoni[@]erasme.ulb.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 0.5M infusion for 24h or standard of care.

Expected outcomes: This controlled trial will assess the safety and efficacy of the 0.5 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: May 15, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, Prisoners)

• Anticipated withdrawal of support within 24 hours

• Traumatic cause of cardiac arrest

• time from ROSC to inclusion > 1hour

• Inclusion in any other interventional trial

Related Conditions & MeSH terms

• Anoxic Brain Injury
• Brain Injuries
• Cardiac Arrest
• Heart Arrest
• Ischemia
• Ischemia Reperfusion Injury
• Reperfusion Injury
• Wounds and Injuries

Intervention

Drug:
• Sodium Lactate Solution
continuous intravenous infusion of half-molar sodium lactate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum NSE	NSE serum levels	48 hours after randomization
Secondary	ICU free days	number of days free from intensive care unit	trough study completion, on average 30 days
Secondary	Mortality	mortality	trough study completion before hospital discharge, on average 60 days
Secondary	Neurological outcome	Neurological outcome measured by Glasgow Outcome Scale at 90 days (3-15, 15 meaning better Neurological outcome	trough study completion, 90 days after randomization
Secondary	Hospital length of stay	Hospital length of stay	trough study completion, on average 60 days
Secondary	Severe adverse events rate	Serious adverse events rate	during study drug administration/day 28 or ICU discharge or death
Secondary	Need for Vasopressors	Need for vasopressors during hospitalization	through study completion, on average 14 days
Secondary	Seizure rate	Seizure rate	through study completion before ICU discharge, on average 14 days
Secondary	Changes in cardiac biomarkers	Troponin I serum levels	at randomization, 24 hours, 48 hours and 72 hours after randomization
Secondary	Changes in brain biomarkers	brain biomarkers including nfL and GFAP	at randomization, after 24 hours, 48 hours and 72 hours
Secondary	Changes in brain metabolism	Brain metabolism measured by PET-IRM	within 24h after randomization
Secondary	Changes in brain perfusion	brain perfusion measured with early perfusion CT scan	within 24h after randomization
Secondary	Changes in echocardiographic parameters (systolic)	Changes systolic cardiac function assessed by echocardiography	at randomization, at 24 hours and 48 hours after randomization
Secondary	Changes in echocardiographic parameters (diastolic)	Changes diastolic cardiac function assessed by echocardiography	at randomization, at 24 hours and 48 hours after randomization
Secondary	identification of optimal perfusion pressure	identification of optimal perfusion pressure with invasive neuromonitoring	through study completion, on average 30 days
Secondary	identification of optimal cerebral oxygen tension	identification of optimal cerebral oxygen tension with invasive neuromonitoring	through study completion, on average 30 days