Antioxidant Treatment with Vitamin C in Cardiac Surgery Patients - A Pilot Randomized Controlled Trial

Phase 1

Conditions: Cardiovascular illness, Intensive care unit (ICU), open-heart surgery
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: CTIS2023-510561-10-00

Lead Sponsor: GCP-Service International West GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion 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

Exclusion Criteria

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