BridgeMD
Antioxidant Treatment with Vitamin C in Cardiac Surgery Patients - A Pilot Randomized Controlled Trial
EU CTIS ID: 2023-510561-10-00
What this study is testing
The primary objective is to assess efficacy of vitamin C compared to standard of care in reducing the systemic inflammatory reaction from before cardiac surgery until 72 hours after surgery.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent prior to study participation
- Adult patients (≥ 18 years)
- Patients undergoing open-heart surgery with the use of cardiopulmonary bypass (CPB), who are defined as high risk based on having (i) combined valve or CABG or multiple valve surgeries, or combined cardiac/aortic surgical procedures and (ii) at least one of the following additional risk factors: a. a high perioperative risk profile, defined as a predicted operative mortality of ≥ 8% (EuroSCORE II) b. Age >70 years c. Clinical Frailty Scale >4 d. Urgent need for cardiac surgery (defined as to be performed within 24 to 48 hours after admission to hospital). e. Left ventricular ejection fraction <35%
- The investigator considers the patient to be suitable for participating in the study
You likely can't join if
- Patients with history of recurrent formation of kidney stones (oxalate urolithiasis) or recent history (within 1 year) of any kidney stones
- Patients who are enrolled in industry sponsored interventional trials. The enrolment of patients included in interventional investigator-initiated trials will be discussed on a case-by-case depending on potential confounders regarding this trial
- Patients with severe renal insufficiency (CKD KDIGO Stage 4/5 or glomerular filtration rate < 30 ml/min)
- Patients with known glucose-6-phosphate dehydrogenase deficiency.
- Patients with known thalassemia, hemochromatosis and sideroblastic anemia.
- Patients with known hypersensitivity to the Investigational Medicinal Product (IMP) or against any of its ingredients
See the full eligibility criteria
- Written informed consent prior to study participation
- Adult patients (≥ 18 years)
- Patients undergoing open-heart surgery with the use of cardiopulmonary bypass (CPB), who are defined as high risk based on having (i) combined valve or CABG or multiple valve surgeries, or combined cardiac/aortic surgical procedures and (ii) at least one of the following additional risk factors: a. a high perioperative risk profile, defined as a predicted operative mortality of ≥ 8% (EuroSCORE II) b. Age >70 years c. Clinical Frailty Scale >4 d. Urgent need for cardiac surgery (defined as to be performed within 24 to 48 hours after admission to hospital). e. Left ventricular ejection fraction <35%
- The investigator considers the patient to be suitable for participating in the study
- Patients with history of recurrent formation of kidney stones (oxalate urolithiasis) or recent history (within 1 year) of any kidney stones
- Patients who are enrolled in industry sponsored interventional trials. The enrolment of patients included in interventional investigator-initiated trials will be discussed on a case-by-case depending on potential confounders regarding this trial
- Patients with severe renal insufficiency (CKD KDIGO Stage 4/5 or glomerular filtration rate < 30 ml/min)
- Patients with known glucose-6-phosphate dehydrogenase deficiency.
- Patients with known thalassemia, hemochromatosis and sideroblastic anemia.
- Patients with known hypersensitivity to the Investigational Medicinal Product (IMP) or against any of its ingredients
- Patients who are pregnant or lactating
- Patients who are receiving high-dose IV vitamin C (enteral or oral vitamin C is allowed) already before surgery (>100 mg/kg/day as daily dose for > 1 week
- Patients who are moribund (not expected to survive the next 72 hours from screening evaluation)
- Patients with severe acid-base or electrolyte imbalances
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.