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

niklinik Würzburg0 个研究点目标入组 60 人开始时间: 2024年5月27日最近更新: 2024年8月19日

试验速览

暂无简介。

•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
•(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%

•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.

发起方

niklinik Würzburg