E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing high-risk open-heart surgery with the use of cardiopulmonary bypass (CPB) |
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E.1.1.1 | Medical condition in easily understood language |
Patients undergoing high-risk open-heart surgery with the use of a heart lung machine |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
We propose a mono-center randomized controlled clinical pilot trial in the University Hospital RWTH Aachen, to gather experience about feasibility, pharmacokinetics and efficacy of vitamin C administration, as well as to increase the evidence about the most appropriate vitamin C administration strategy in cardiac surgery patients. We will evaluate the oxidation-reduction-potential (ORP) as a feasible, readily accessible tool to measure the efficacy of an antioxidant. We will gather first evidence of vitamin C administration on blood vitamin C levels, oxidative stress and inflammation and to gain first impressions about the clinical significance of a vitamin C treatment in cardiac surgery patients. |
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E.2.2 | Secondary objectives of the trial |
The secondary outcomes will assess the influence of vitamin C on inflammation and organ dysfunction. Patient outcomes, such as ICU- and hospital length of stay, hemodynamic and ventilator parameters and mortality will be evaluated as well.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult cardiac surgery patients Given informed consent High risk cardiac surgery, defined by the presence of one or more of the following: a) Planned combined valve/CABG or multiple valve surgeries, or combined cardiac/aortic surgical procedures b) Any cardiac surgery with a high perioperative risk profile, defined as a predicted operative mortality of ≥ 5% (EuroSCORE II).
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E.4 | Principal exclusion criteria |
Pregnant or lactating patients Clinical kidney failure or recurring formation of kidney stones Glucose-6-phosphatase dehydrogenase deficiency, Hemochromatosis or disease requiring frequent blood transfusions Patients already receiving an intense nutrition support (home parenteral or enteral nutrition) in addition to normal nutrition on hospital admission Known allergy to study nutrients Death expected within 96 hours after admission due to severity of disease Enrolment in an industry sponsored randomized trial within the last 30 days
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E.5 End points |
E.5.1 | Primary end point(s) |
Analysis of a blood sample with the RedoxSYS Diagnostic SystemTM (Aytu BioScience, Inc., USA) Analysis of a blood sample for its vitamin C content
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
pre surgery End of cardio pulmonary bypass post-OP Daily for 96h after surgery |
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E.5.2 | Secondary end point(s) |
ICU length of stay Hospital length of stay ICU readmission rate Hospital readmission rate Lab work: IL-6, CRP, PCT, leukocytes SOFA Score (daily records) Ventilation data (hours and mode of ventilation) Hemodynamic parameters (heart rate, blood pressure, vasopressors) Duration and dosage of sedation Richmond Agitation Scale (RAS) Confusion Assessment Method for the ICU (CAM-ICU) Laboratory analyses as per hospital standard: blood count, electrolytes, and markers of organ dysfunctions (creatinine, liver enzymes, hemoglobin, infection parameters) Need for ventilation, vasopressors, renal replacement therapy Surgical reevaluation, hemorrhage, thromboembolic events, cardiovascular events, infection and sepsis
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
pre surgery End of cardio pulmonary bypass post-OP Daily for 96h after surgery |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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assement of health status via telephone 30 days after surgery |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |