CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 270 enrolled
Drug / intervention
Vitamin C +2 moredrug
Likely dose
Vitamin C 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03509662
NCT03509662Phase 2Completed

Early High-dose Vitamin C in Post-cardiac Arrest Syndrome

Amsterdam UMC, location VUmc·interventional·Posted Apr 26, 2018·Updated Mar 10, 2025

In Brief

A Phase 2 clinical trial evaluating Vitamin C, Thiamine, and 1 other intervention for Cardiac Arrest. Completed, enrolled 270 participants across 1 site.

Detailed Summary

Only half of the patients suffering from cardiac arrest arrive at the hospital alive. Of these survivors, more than 50% will still die or remain severely disabled. During cardiac arrest ischemia causes damage to the vital organs, especially the brain. When with return of spontaneous circulation oxygen is re-offered to the ischemic organs, massive amounts of reactive oxygen species (ROS) are produced. These ROS can further increase the damage to the myocardium and brain (reperfusion injury). Vitamin C is the primary circulating antioxidant. It scavenges free radicals and reduces the production of ROS. In a recent study we demonstrated that vitamin C plasma levels are deficient in \~60% of the patients after cardiac arrest, probably due to massive consumption. Vitamin C deficiency reduces the protection against oxidative stress. Intravenous supplementation is needed to restore deficiency and the antioxidative effect of vitamin C is much more potent if it is administered in a supraphysiological dose (≥ 3 g per day). Its strong antioxidative effect may reduce damage to the circulation and to brain, heart and other organs. Beneficial effects of high dose i.v. vitamin C after cardiac arrest have been demonstrated in preclinical studies, but not in patients. The investigators hypothesize that vitamin C can reduce organ damage, especially cerebral injury, if administered for a short period as a high i.v. dose during the very early phase of reperfusion after cardiac arrest. Objectives: * To determine whether an early high dose i.v. vitamin C can improve organ function, especially neurological outcome, in patients after cardiac arrest * 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Arrest
CountriesNetherlands

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 26, 2018
Enrollment StartOct 7, 2019
Primary CompletionFeb 15, 2024
Study CompletionAug 29, 2024
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 8.2 years ago

Interventions

Vitamin Cdrug

Vitamine C will be administered intravenously as ascorbic acid (ascorbinezuur CF 100 mg/ml, Centrafarm BV, Etten Leur, Netherlands).

Thiaminedrug

All patients will receive thiamine 200 mg q 12 hourly for 4 days to limit the conversion of vitamin C to oxalate.

Placebosdrug

One group receives a placebo.