Intravenous amino acid therapy for kidney protection in cardiac surgery: a multi-centre randomised blinded placebo controlled clinical trial - PROTECTIO

OSPEDALE SAN RAFFAELE0 个研究点目标入组 3,500 人开始时间: 2021年1月7日最近更新: 2021年1月11日

适应症

试验速览

暂无简介。

•Aged 18 years; Scheduled cardiac surgery; Expected to stay in ICU at least one night after surgery; Signed informed consent
•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 1750
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1750

•1. Patient currently enrolled into another randomized clinical trial;2. Patient currently receiving or scheduled for intermittent or continuous renal replacement therapy; 3. Patients with CKD of equal or more than CKD stage IV (GFR<30 ml/min/1.73 m2); 4. Patient with a kidney transplant: 5. Patient is not expected to survive ICU or hospital discharge;
•6. Patient previously been enrolled and randomized into this study: 7. Patient has severe liver disease (Child-Pugh score >7 points); 8. Patient has a hypersensitivity (known allergy) to one or more of the included amino acids; 9. Patient has a congenital alteration of amino acid metabolism; 10. Pregnant or currently breastfeeding patients

发起方

OSPEDALE SAN RAFFAELE