Antioxidant Treatment with Vitamin C in Cardiac Surgery Patients – A Pilot Randomized Controlled Trial

Phase 2

Conditions: ICD 5-35 and 5-36, open heart surgery with use of cardiopulmonary bypass

Registration Number: DRKS00033611

Lead Sponsor: niklinik Würzburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 60

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

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.

Study & Design

Study Type: interventional

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. <br>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 Outcome Measures

Name	Time	Method
Secondary objectives are to<br>- 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.<br>- Collect information on safety parameters including (adverse events).<br><br>Exploratory objectives are to:<br>-Explore the feasibility of the study including recruitment rate and compliance rate.<br>-Evaluate whether a clear distinction can be made between the intervention- and control-group regarding the vitamin C serum levels and intracellular vitamin C.<br>-Collect further information on efficacy and safety parameters<br>