ADVANCE-CSX Pilot – Antioxidant Treatment with Vitamin C in Cardiac Surgery Patients – a Clinical Pilot Study
- Conditions
- Patients undergoing high-risk open-heart surgery with the use of cardiopulmonary bypass (CPB)Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-001086-32-DE
- Lead Sponsor
- RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method