Study on the Effectiveness of High-Dose Vitamin C for Patients with Shock After Cardiac Arrest

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What is this study about?

This clinical trial is focused on studying the effects of high-dose vitamin C, also known as ascorbic acid, in patients who have experienced a cardiac arrest and are in shock afterward. Cardiac arrest is a serious condition where the heart suddenly stops beating, and shock is a state where the body is not getting enough blood flow. The trial aims to see if vitamin C can help reduce the need for medications called vasopressors, which are used to increase blood pressure, within the first three days after the cardiac arrest.

Participants in the study will receive vitamin C through an intravenous (IV) injection, which means it is given directly into a vein. The study will compare the effects of vitamin C with standard treatments, which may include other medications like dobutamine, epinephrine (also known as adrenaline), noradrenaline (also known as norepinephrine), and thiamine hydrochloride (vitamin B1). Some participants may receive a placebo instead of vitamin C. The study will monitor how quickly patients can stop using vasopressors and will also look at other outcomes, such as survival rates and neurological health, over a period of up to 28 days.

The purpose of this study is to determine if early treatment with high-dose vitamin C can improve recovery in patients who have suffered a cardiac arrest and are experiencing shock. The trial will help researchers understand if vitamin C can be a beneficial addition to the current standard treatments for this condition.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose and procedures. You will be asked to provide consent to participate in the trial.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes checking if you are still comatose with a Glasgow coma scale score of less than 8, and if you have experienced an out-of-hospital cardiac arrest (OHCA) with a return of spontaneous circulation (ROSC) in less than 60 minutes.

You must be receiving a continuous infusion of norepinephrine or epinephrine at a rate of at least 0.2 micrograms per kilogram per hour to maintain a mean arterial pressure of at least 65 mmHg.

3 treatment administration

You will receive a high-dose of vitamin C intravenously. This is a solution for injection administered through an IV.

Other medications you may receive include dobutamine, epinephrine, noradrenaline tartrate, and thiamine hydrochloride. These are also administered as solutions for injection or infusion.

4 monitoring and follow-up

Your response to the treatment will be closely monitored. The primary goal is to assess the reduction in the need for vasopressors within the first 3 days after the cardiac arrest.

Secondary assessments include monitoring the incidence of death by refractory shock within 7 days, neurological outcomes at day 28, the maximum dose of vasopressors within 3 days, changes in organ function scores, and arterial lactate levels at day 3.

5 completion of trial

The trial is expected to conclude by May 1, 2025. Your participation will contribute to understanding the efficacy of high-dose vitamin C in treating post-cardiac arrest shock.

Who Can Join the Study?

Patients must be unconscious (Glasgow coma scale less than 8). The Glasgow coma scale is a way to measure how awake and responsive a person is.
Patients must have experienced an out-of-hospital cardiac arrest (OHCA) that is believed to be caused by heart problems, with a return of spontaneous circulation (ROSC) in less than 60 minutes. ROSC means the heart started beating again on its own.
Patients must be receiving a continuous infusion of norepinephrine or epinephrine at a dose of at least 0.2 micrograms per kilogram per hour, within 4 hours after the cardiac arrest, for at least 30 minutes per hour. This is to keep the mean arterial pressure (MAP) at or above 65 mmHg. MAP is a measure of the average blood pressure in a person’s arteries during one cardiac cycle.
Both male and female patients can participate.
Patients of all age groups are eligible.

Who Cannot Join the Study?

Patients who have had a cardiac arrest cannot participate. A cardiac arrest is when the heart suddenly stops beating.
Patients who are not within the specified age range cannot participate. The age range for this study is from 18 to 65 years old.
Patients who are not able to give their own consent cannot participate. This means if someone cannot understand the study and agree to join on their own, they cannot be part of it.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a known allergy to vitamin C cannot participate. Vitamin C is a nutrient found in various foods and sold as a dietary supplement.
Patients who are currently participating in another clinical trial cannot participate.
Patients with severe kidney problems cannot participate. The kidneys are organs that help filter waste from the blood.
Patients with a history of certain types of cancer cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer	Toulon	France
Centre Hospitalier de Dieppe	Dieppe	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Grand Hopital De L Est Francilien	Meaux	France
Chorale Du Centre Hospitalier De Lens	Lens	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Bethune Beuvry	Beuvry	France
Centre Hospitalier De Valenciennes	Valenciennes	France
Czqhir Hgsbhtgacmd Imstzdvlnqydp Nakp Adaaukbq	Charleville-Mézières	France
Cljbhb Homlpiiysfy Dlugpinrqtdjl	Arras	France
Ctssxa huafhhcrztw Mawtx	Melun	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.04.2023

Trial locations

Investigated drugs:

Vitamin C is being tested in this clinical trial. It is a vitamin that is usually found in fruits and vegetables. In this study, it is given in high doses through an IV, which means it goes directly into the bloodstream. The goal is to see if it can help people who have had a heart attack and are in shock by reducing their need for other medications that help maintain blood pressure. The researchers want to find out if this high-dose vitamin C can help patients recover better in the first few days after their heart attack.

Investigated diseases:

Cardiac arrest

Cardiac Arrest – Cardiac arrest is a sudden loss of heart function, leading to a cessation of blood flow to the body’s organs. It occurs when the heart’s electrical system malfunctions, causing an irregular heartbeat or arrhythmia. This condition can happen unexpectedly and requires immediate medical attention. During cardiac arrest, the heart stops pumping blood, which can lead to a loss of consciousness and absence of pulse. If not treated promptly, it can result in severe damage to the brain and other vital organs due to lack of oxygen. The progression of cardiac arrest is rapid, and it can occur within minutes, necessitating urgent intervention to restore normal heart function.

Trial ID:

2022-500717-64-00

Protocol code:

VICEPAC

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of High-Dose Vitamin C for Patients with Shock After Cardiac Arrest

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?