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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

13 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated drugs

  • 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.

What is already known about the treatment

Vitamin C (Ascorbic acid) - A water-soluble vitamin administered intravenously during cardiac surgery and post-operative care in intensive care units. This essential nutrient acts as a powerful antioxidant by neutralizing free radicals and reducing oxidative stress at the cellular level, which helps minimize inflammation during and after major surgical procedures. In cardiac surgery, high-dose vitamin C is being investigated for its potential to decrease systemic inflammatory responses, which are common complications in open-heart surgery patients. It belongs to the pharmacological class of antioxidant vitamins and is considered safe with a well-established safety profile in clinical medicine.

Investigated diseases

  • 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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510561-10-00Protocol codeThe ACCURATE StudyEstimated enrolment60 patientsSponsorGcp-Service International West GmbH

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).