Pilot study about the use of intravenous Vitamin C for the prevention of Reperfusion Syndrome in Orthotopic Liver Transplantation from a cadaver donor.

Phase 1

Active, not recruiting

• Conditions: Reperfusion syndrome; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-000123-39-ES
• Lead Sponsor: Fundación Investigación Biomédica Hospital Ramón y Cajal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-28
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified