Hypertonic Lactate After Cardiac Arrest
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sodium Lactate Solution.
- Who it may be relevant to
- Registry conditions: Cardiac Arrest, Ischemia Reperfusion Injury, Anoxic Brain Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Sodium Lactate Solution
continuous intravenous infusion of molar sodium lactate
Primary outcome measures
- serum NSE [Time frame: 48 hours after randomization]
Secondary outcome measures (12)
- ICU length of stay [Time frame: trough study completion, on average 30 days]
- Mortality [Time frame: trough study completion before hospital discharge, on average 90 days]
- Neurological outcome [Time frame: trough study completion, 90 days after randomization]
- Hospital length of stay [Time frame: trough study completion, on average 60 days]
- Vasopressors equivalent dose [Time frame: through study completion, during the first 48 hours after resuscitation]
- Seizure rate [Time frame: through study completion before ICU discharge, on average 14 days]
- Changes in cardiac biomarkers [Time frame: at randomization, 24 hours, 48 hours and 72 hours after randomization]
- Changes in brain biomarkers [Time frame: at randomization, after 24 hours, 48 hours and 72 hours]
- Severe adverse events rate [Time frame: during study drug administration/day 28 or ICU discharge or death]
- Changes in brain metabolism [Time frame: within 24h after randomization]
- Changes in brain perfusion [Time frame: within 24h after randomization]
- Changes in echocardiographic parameters (systolic) [Time frame: at randomization, at 24 hours and 48 hours after randomization]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Erasme Hospital, Brussels University Hospital (HUB) — Brussels
Identifiers
NCT: NCT05004610 · SRB2021260