Brain damage after cardiac arrest
Conditions
Interventions
Product Name: acylated ghrelin
Product Code: G-3370-R
Pharmaceutical Form: Lyophilisate for suspension for injection
INN or Proposed INN: Acyl-Ghrelin
Sponsors
University of Twente
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 years • Out of hospital cardiac arrest • Successful cardiopulmonary resuscitation • Return of spontaneous circulation =12 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 83 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
Exclusion criteria: • Age <18 years • A known progressive neurological disease • Expected death within 48 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We aim to estimate 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 Objective: 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 outcomes, including blood pressure, treatment with inotropic medication, treatment with vasopression, LVAD, cardiac biomarkers, and need for defibrillation ;Primary end point(s): The primary outcome measure will be functional outcome as expressed as the score on the cerebral performance category (CPC) at 6 months. ;Timepoint(s) of evaluation of this end point: 3 months, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes include case fatality at one week and 6 months, time to awaken (time interval between resuscitation and GCS score of 14), EMV score and estimated CPC score at 1 week, CPC score at 3 and 12 months, and cognitive functioning at 12 months. Cardiovascular secondary outcome measures are: 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 Biomarkers are: 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 Gastro-intestinal outcome measure is: gastric residual volume (day 1-7, during ICU admission) ;Timepoint(s) of evaluation of this end point: Daily after administering medication/placebo for a week; 1 week, 3 months, 12 months | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
Rijnstate Hospital
Outcome results
None listed