Phase II clinical trial, randomized, double blind, masked, controlled with physiological serum about the efficacy of intravenous administration of vitamin C during the anhepatic phase of liver transplantation to prevent the onset of reperfusion syndrome - VITACTOH

Fundación Investigación Biomédica Hospital Ramón y Cajal0 个研究点目标入组 70 人开始时间: 2020年2月28日最近更新: 2020年7月13日

试验速览

暂无简介。

•Patients, who after receiving the information about the design, the purposes of the study, the possible risks that may arise from it and that at any time they may deny their collaboration, give their informed consent in writing to take part in the study.
•Be between 18 and 67 years of age
•Understand the purpose of the study
•Patients who are going to undergo HT from a cadaver donor and who have been included in the waiting list after the relevant evaluation of the patient selection committee.
•Pregnancy test in urine performed in the 7 days prior to the start of treatment under study in premenopausal women is negative or <2 years after menopause
•Women of childbearing age (between menarche and menopause, defined as absence of menstruation for 12 consecutive months) and men with a fertile partner must commit to using an effective contraceptive method (such as surgical sterilization, double barrier method, contraceptives) oral or hormonal contraceptive implants).
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Pregnancy or planning to become pregnant during the course of the study. Lactation.
•Known or suspected hypersensitivity to intravenous vitamin C or any of its excipients (methyl parahydroxybenzoate - E-218 -, propyl parahydroxybenzoate - E-216 -).
•Nephrolithiasis or history of nephrolithiasis.
•Glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis).
•Hyperoxaluria.
•Hyperuricemia / gout (risk of uric acid deposits).
•Hemochromatosis.
•Sickle cell disease.
•Being treated with deferoxamine, indinavir, cyanocobalamin (Vitamin B12), cyclosporine, disulfirate or iron.
•Preoperative renal failure defined as serum creatinine greater than 1.2 mg / dl in women and 1.3 mg / dl in men.
•Split type liver transplant.
•Fulminant hepatitis as an indication of transplant.
•Graft from living-related donor or donor in asystole

发起方

Fundación Investigación Biomédica Hospital Ramón y Cajal