Postanoxic encephalopathy, postanoxic, coma after cardiac arrest, ghrelin administration, neuroprotection
Conditions
Interventions
Intravenous treatment with acylated ghrelin 600micrg twice daily for 1 week vs. placebo.
Sponsors
University of Twente
Clinical neurophysiology
Drienerlolaan 5
7522NB Enschede
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study a subject must meet the following criteria: - Age ≥18 years - Out of hospital cardiac arrest - Successful cardiopulmonary resuscitation - Return of spontaneous circulation ¡Ü12 hours ago - GCS score on admission ≤ 8 or suspected coma in patients who are sedated - Admission to intensive care unit - Hemodynamic and respiratory stability as determined by the treating intensive care physician, with the minimum requirement of mean arterial pressure > 65 mmHg. Treatment with inotropes, vasopressors or IABP is allowed.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Age <18 years - A known progressive neurological disease - Expected death within 48 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We aim to measure safety and efficacy of intravenous treatment with acyl-ghrelin to promote cerebral recovery in comatose patients after cardiac arrest. Safety will be monitored throughout hospitalization and during follow-up using all AEs reported, and by interim analyses by an independent DSMB. Efficacy will be measured by the primary outcome measure, i.e. functional recovery as measured by the Cerebral Performance Category (CPC) scale at six months after cardiac arrest. | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate efficacy of ghrelin to modify: 1. Case fatality 2. Time to awaken (time interval between resuscitation and Glasgow Coma Scale (GCS) score of 14) 3. Long term outcome: CPC and cognitive functioning at 12 months 4. Cardiovascular measures: • Mean arterial blood pressure day 1-7 (mean, highest, lowest) • Heart rate day 1-7 (mean, highest, lowest) • Arrhythmia day 1-7: yes / no. If yes: type of arrhythmia • Cumulative dose of vasopressive medication day 1-7 • Cumulative dose of inotropic medication day 1-7 • Sequential Organ Failure Assessment score day 1-7 • Kidney function day expressed as GFR day 1-7 • CVVH day 1-7: yes / no • Assist devices day 1-7: yes / no 5. Biomarkers • Cardiac: troponine and CK / CK-MB ratio at day 0, 1, 2 or 3 • Neurological: NSE day 1, 2, 3 • Endocrinological: cortisol, growth hormone, prolactine, ACTH, IGF-1 day 1, 2, 3 6. Gastro-intestinal: gastric residual volume (day 1-7, during ICU admission) | — |
Contacts
Public ContactJ. Hofmeijer
Department of Neurology at Rijnstate
Outcome results
None listed