ICD 5-35 and 5-36, open heart surgery with use of cardiopulmonary bypass
Conditions
Interventions
Group 1: Vitamin C intravenously (50 mg/kg/dosage) over a 1-hour infusion:
- after induction of anesthesia before surgery
- at admission to the ICU
- and then every 6 hours until discharge from the IC
Sponsors
Charité– Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: High risk patients undergoing open-heart surgery with the use of cardiopulmonary bypass (CPB). 1. Written informed consent prior to study participation. 2. Adult patients (= 18 years). 3. Patients undergoing open-heart surgery with the use of cardiopulmonary bypass (CPB), who are defined as high risk based on having (i) combined valve/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 Score >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%
Exclusion criteria
Exclusion criteria: Patients 1. With history of recurrent formation of kidney stones (oxalate urolithiasis) or recent history (within 1 year) of any kidney stones. 2. Patients with severe renal insufficiency (glomerular filtration rate < 30 ml/min). 3. With known glucose-6-phosphate dehydrogenase deficiency. 4. With known thalassemia, hemochromatosis and sideroblastic anemia. 5. With known hypersensitivity to the Investigational Medicinal Product (IMP) or against any of its ingredients. 6. Who are pregnant or lactating. 7. Who are receiving high-dose IV vitamin C already (enteral or oral vitamin C is allowed). 8. Who are moribund (not expected to survive the next 72 hours from screening evaluation). 9. With severe acid-base or electrolyte imbalances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the curve of serum levels of IL-6 from baseline to 72 hours after surgery. Interleukin 6 is measured at the following time points: preoperatively, intraoperatively after separation from the heart-lung machine, postoperatively upon admission to the intensive care unit, and then every 24 hours up to 72 hours postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are to - Further evaluate efficacy of the investigational medicinal product by its effects on clinically relevant outcomes such as organ dysfunction, the duration of mechanical ventilation, intensive care unit (ICU) and hospital length of stay and mortality rates. - Collect information on safety parameters including (adverse events). Exploratory objectives are to: -Explore the feasibility of the study including recruitment rate and compliance rate. -Evaluate whether a clear distinction can be made between the intervention- and control-group regarding the vitamin C serum levels and intracellular vitamin C. -Collect further information on efficacy and safety parameters | — |
Countries
Germany
Contacts
Public ContactAileen Hill
Uniklinik RWTH Aachen
Outcome results
None listed