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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Lactate Solution | Drug | continuous intravenous infusion of molar sodium lactate |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum NSE | NSE serum levels | 48 hours after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Filippo Annoni, MD | Contact | 0483141483 | filippo.annoni@erasme.ulb.ac.be | |
| Fabio S Taccone, MD,PhD | Contact | fabio.tacconei@erasme.ulb.ac.be |
| Name | Affiliation | Role |
|---|---|---|
| Filippo Annoni, MD | Erasme University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme Hospital, Brussels University Hospital (HUB) | Recruiting | Brussels | Belgium | 1070 | Belgium |
IPD may be available on reasonable request to other researchers
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D015427 | Reperfusion Injury |
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D011183 | Postoperative Complications |
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| 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 |
| Hospital length of stay | Hospital length of stay | trough study completion, on average 60 days |
| Vasopressors equivalent dose | Vasopressors equivalent dose during the first 48 hours after resuscitation | through study completion, during the first 48 hours after resuscitation |
| 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 |
| Severe adverse events rate | Serious adverse events rate | during study drug administration/day 28 or ICU discharge or death |
| 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 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |