Patients undergoing high-risk open-heart surgery with the use of cardiopulmonary bypass (CPB)
Conditions
Interventions
Trade Name: Vitamin C 1000 Injektionslösung
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: vitamin C
CAS Number: 50-81-7
Other descriptive name: ACIDUM ASCORBICUM D6
Concentration un
Sponsors
RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty
Eligibility
Sex/Gender
All
Inclusion criteria
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). 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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. ;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 ;Timepoint(s) of evaluation of this end point: pre surgery End of cardio pulmonary bypass post-OP Daily for 96h after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;Timepoint(s) of evaluation of this end point: pre surgery End of cardio pulmonary bypass post-OP Daily for 96h after surgery | — |
Countries
Germany
Contacts
Public ContactSebastian Wendt
University Hospital RWTH Aachen
Outcome results
None listed