Patients admitted to the Intensive Care after out-of-hospital cardiac arrest with return of spontaneous circulation, ventricular fibrillation or ventricular tachycardia as first registered cardiac rhythm and EMV-score =8 MedDRA version: 20.0 Level: PT Classification code 10078202 Term: Post cardiac arrest syndrome System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Ascorbic acid 5 gr/50 ml
Product Code: 1.5 gr and 5 gr
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Ascorbic acid
Other descriptive name: ASCORBIC ACID PH EU
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients suffering an out-of-hospital cardiac arrest with return of spontaneous circulation, ventricular fibrillation or ventricular tachycardia as first registered cardiac rhythm and EMV-score =8 will be included. 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 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 230
Exclusion criteria
Exclusion criteria: Patients with pre-existent terminal renal insufficiency (i.e. receiving renal replacement therapy (RRT)), known glucose 6-phosphate dehydrogenase deficiency (risk of hemolysis), history of urolithiasis, oxalate nephropathy, hemochromatosis or treatment limitations will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To determine whether an early high dose i.v. vitamin C can improve organ function, especially neurological outcome, in patients after cardiac arrest ;Secondary Objective: - To explore the optimal dosing regimen for high dose i.v. vitamin C - To investigate in vitro the difference in effect of plasma obtained from post cardiac arrest patients treated with placebo, 3 gr/day or 10 gr/day vitamin C on endothelial cell viability and underlying oxidative pathways. ;Primary end point(s): We will determine organ failure at 96 hours measured by the delta (?) Sequential Organ Failure Assessment (SOFA) score. ?SOFA score is defined as the difference between SOFA admission and SOFA at 96 hour. Death at 96-hours will be counted as the maximum SOFA score (24 points). ;Timepoint(s) of evaluation of this end point: After 96 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As secondary outcomes we will investigate: neurological outcome (Maximal Glasgow Coma Score at 96-h and and the end of ICU-stay; Cerebral Performance Categories scale and Modified Rankin Scale at 30 and 180 days; HUI-3 questionnaire at 180 days; neuron-specific enolase day 1, 2 and 3); clinical parameters (IC- and hospital stay, 30-day and 90-day mortality), organ injury (myocardial injury measured by troponin and CK-MB (maximum day 1), lung injury score, ventilation time, renal function, need of renal replacement therapy, IC-acquired weakness (Medical Research Council score), delirium (CAM-ICU score), mitoPO2, oxidative stress parameters (such as F2-isoprostanes and oxidation reduction potential (ORP)), anti-oxidant capacity (AOC) and vitamin C plasma concentrations. In vitro experiments: To determine the different effect of 3 or 10 gram vitamin C or placebo on the underlying oxidative pathways we will investigate how plasma obtained from the trial patients affects cultured human systemic microvascular endothelial cells with regard to endothelial cell viability, ROS production intracellular vitamin C concentrations, NADPH-oxidase expression, p47Phox expression, endothelial barrier function and mitochondrial respiratory chain function.;Timepoint(s) of evaluation of this end point: After 96 hours and at the end of ICU-stay. Neurological outcome will also be evaluated after 30 days and after 180 days. | — |
Countries
Netherlands
Contacts
Public ContactDept. of Intensive Care
VU University Medical Center
Outcome results
None listed