Study of Vitamin C (Ascorbic Acid) in Patients Undergoing Open-Heart Surgery to Reduce Post-Surgery Inflammation

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What is this study about?

This study focuses on patients undergoing open-heart surgery who require treatment in the Intensive Care Unit (ICU). The research examines the effects of Vitamin C (ascorbic acid) given through intravenous injection in patients who undergo heart surgery using a cardiopulmonary bypass. The purpose is to determine if Vitamin C can help reduce inflammation that occurs in the body after cardiac surgery.

During the study, participants will receive either Vitamin C or standard medical care. The treatment with Vitamin C will be administered for up to 7 days, with doses calculated based on body weight. The maximum daily dose is 200 mg per kilogram of body weight, with a total maximum dose of 1400 mg per kilogram over the treatment period.

The study will monitor various aspects of recovery after surgery, including heart function, complications, and the body’s inflammatory response. Patients will be followed during their hospital stay and for several months afterward to assess their recovery and overall health status. The treatment involves the medication Pascorbin, which contains Vitamin C as its active ingredient.

1 Initial treatment phase

You will receive vitamin C or standard treatment before cardiac surgery

The treatment will be administered through an intravenous line (directly into your vein)

The medication used is Pascorbin®, containing 150 mg/ml of vitamin C as an injection solution

2 Surgery phase

You will undergo open-heart surgery using a heart-lung machine

The medical team will monitor your condition throughout the procedure

3 Post-surgery monitoring – first 72 hours

Your blood will be tested regularly to measure inflammation markers

The medical team will monitor your heart function

Your overall health status will be assessed daily

You will receive care in the intensive care unit (ICU)

4 Extended monitoring period

Your recovery will be monitored during your hospital stay

The medical team will track any complications or side effects

Regular assessments will include heart function and general health status

5 Follow-up period

Your health status will be monitored for up to 6 months after surgery

The medical team will assess your heart function and overall recovery

Any complications or health issues will be documented

Who Can Join the Study?

Patient must provide written informed consent before participating in the study
Patient must be 18 years or older
Patient must be scheduled for open-heart surgery using cardiopulmonary bypass (a machine that temporarily takes over the function of the heart and lungs during surgery)
Patient must be undergoing one of these procedures:
- Combined valve surgery
- CABG (coronary artery bypass grafting – a surgery to improve blood flow to the heart)
- Multiple valve surgeries
- Combined cardiac and aortic procedures
Patient must also have at least one of these additional risk factors:
- High risk of complications with predicted mortality of 8% or higher based on EuroSCORE II (a risk assessment tool)
- Age over 70 years
- Frailty score greater than 4 (indicating increased vulnerability and need for assistance)
- Need for urgent cardiac surgery within 24-48 hours after hospital admission
- Heart pumping capacity (left ventricular ejection fraction) less than 35%
The study doctor must consider the patient suitable for participation

Who Cannot Join the Study?

Age below 18 years or above 75 years
Known allergic reaction to vitamin C supplements
Currently participating in other clinical trials
Presence of severe kidney disease (as vitamin C processing might be affected)
History of heart attacks in the past 3 months
Emergency cardiac surgery (unplanned heart surgery)
Pregnancy or breastfeeding
Having received organ transplants
Blood clotting disorders (conditions that affect blood’s ability to form clots)
Active cancer treatment
Taking medications that interact with vitamin C
Chronic inflammatory conditions (long-term diseases causing inflammation)
History of kidney stones
Severe liver problems
Inability to provide informed consent

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Universitaetsklinikum Aachen AöR	Aachen	Germany
Deutsches Herzzentrum Berlin	Berlin	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	03.06.2024

Trial locations

Investigated drugs:

Ascorbic Acid

Vitamin C is an essential nutrient and antioxidant that helps protect cells from damage. In this trial, it is being studied for its potential to reduce inflammation in patients undergoing cardiac surgery. Vitamin C is a well-known supplement that may help support the body’s natural healing processes and immune system during surgical procedures.

Standard of care refers to the normal medical treatment that patients typically receive during and after cardiac surgery. This includes the usual medications and procedures that are part of regular cardiac surgery care protocols.

Cardiovascular Disease – A broad category of conditions affecting the heart and blood vessels, which can develop gradually over time. The condition involves the narrowing or blocking of blood vessels that can lead to heart attacks, chest pain, or stroke. It often involves the buildup of fatty deposits in the arteries and can affect the heart’s ability to pump blood effectively.

Post-Cardiac Surgery Inflammatory Response – A natural reaction of the body that occurs after open-heart surgery, characterized by the release of inflammatory substances. The condition involves increased levels of various inflammatory markers in the blood, including interleukins and C-reactive protein. This response can affect multiple organ systems and typically develops within hours after surgery.

Atrial Fibrillation – An irregular and often rapid heart rhythm that occurs when the upper chambers of the heart beat out of coordination with the lower chambers. This condition can develop after cardiac surgery and causes irregular heartbeats, often felt as palpitations. The irregular rhythm can affect how efficiently the heart pumps blood.

Systemic Inflammatory Response Syndrome – A widespread inflammatory state affecting the entire body, which can occur after major surgery such as open-heart procedures. The condition is characterized by elevated inflammatory markers and can affect multiple body systems simultaneously. It typically develops within the first few days after a triggering event such as surgery.

Trial ID:

2023-510561-10-00

Protocol code:

The ACCURATE Study

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Vitamin C (Ascorbic Acid) in Patients Undergoing Open-Heart Surgery to Reduce Post-Surgery Inflammation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?