Antioxidant Treatment with Vitamin C in Cardiac Surgery Patients - A Pilot Randomized Controlled Trial
- Conditions
- Cardiovascular illness, Intensive care unit (ICU), open-heart surgery
- Registration Number
- 2023-510561-10-00
- Lead Sponsor
- GCP-Service International West GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 60
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
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The area under the curve of serum levels of IL-6 from baseline to 72 hours after surgery The area under the curve of serum levels of IL-6 from baseline to 72 hours after surgery
- Secondary Outcome Measures
Name Time Method Urine output during the ICU length of stay Urine output during the ICU length of stay
30 day and 6-month all-cause mortality 30 day and 6-month all-cause mortality
Days alive and out of hospital Days alive and out of hospital
Time to discharge alive (TDA) Time to discharge alive (TDA)
Persistent organ dysfunction and death Persistent organ dysfunction and death
ICU and hospital length of stay ICU and hospital length of stay
ICU and hospital readmission rates ICU and hospital readmission rates
Area under the curve (AUC) of inflammatory markers (IL-1b, TNF-α and IFN-γ) Area under the curve (AUC) of inflammatory markers (IL-1b, TNF-α and IFN-γ)
Absolute values of daily measurements of C Reactive Protein (CRP), procalcitonin (PCT) and leukocytes during ICU stay Absolute values of daily measurements of C Reactive Protein (CRP), procalcitonin (PCT) and leukocytes during ICU stay
Daily overall Sequential Organ Failure Assessment (SOFA) Score Daily overall Sequential Organ Failure Assessment (SOFA) Score
Duration and type (invasive or non-invasive) of mechanical ventilation Duration and type (invasive or non-invasive) of mechanical ventilation
Duration and dosage of sedative agents used postoperatively Duration and dosage of sedative agents used postoperatively
Occurrence of malignant arrhythmias Occurrence of malignant arrhythmias
Occurrence of atrial fibrillation Occurrence of atrial fibrillation
Left ventricular ejection fraction (LVEF) Left ventricular ejection fraction (LVEF)
New York Heart Association (NYHA) Classification New York Heart Association (NYHA) Classification
Number of cerebral ischemic or hemorrhagic events Number of cerebral ischemic or hemorrhagic events
Clinical Frailty Scale (CFS) Clinical Frailty Scale (CFS)
Daily Confusion Assessment Method for the ICU (CAM-ICU) Score Daily Confusion Assessment Method for the ICU (CAM-ICU) Score
Number of post operative complications including surgical re-evaluation, severe hemorrhage requiring surgical intervention, thromboembolic events requiring intervention, infection and sepsis Number of post operative complications including surgical re-evaluation, severe hemorrhage requiring surgical intervention, thromboembolic events requiring intervention, infection and sepsis
Adverse Events leading to discontinuation/Adverse Events at least possibly related to the IMP/Serious Adverse Events and Adverse Events of Special Interest Adverse Events leading to discontinuation/Adverse Events at least possibly related to the IMP/Serious Adverse Events and Adverse Events of Special Interest
Entzündungsmarker, die mit Point-of-Care-Methoden am Krankenbett analysiert werden (z. B. IL-1, IL-6, IL-8, IL-10, TNF-α, IFN-γ, CRP, PCT, D-Dimer, Ferritin) Entzündungsmarker, die mit Point-of-Care-Methoden am Krankenbett analysiert werden (z. B. IL-1, IL-6, IL-8, IL-10, TNF-α, IFN-γ, CRP, PCT, D-Dimer, Ferritin)
Trial Locations
- Locations (3)
Rheinische Friedrich-Wilhelms-Universitaet Bonn
🇩🇪Bonn, Germany
Universitaetsklinikum Aachen AöR
🇩🇪Aachen, Germany
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn🇩🇪Bonn, GermanyMaria WittmannSite contact+4915158233192maria.wittmann@ukbonn.de