Evaluation of the effect of pretransplant, high-dose intravenous vitamin C in prevention of delayed graft function after deceased kidney transplantation

Clinical evaluation of Delayed graft function (DGF) after kidney transplantation between the vitamin C arm and the placebo

A double-blind, randomized clinical trial with a control group and a placebo group design of 50 patients

- This study will be conducted in a double blinded clinical trial with placebo in the kidney transplantation section of Imam Khomeini Hospital. - The study will begin after the receipt of the code of ethics and receive the approval of the Ethics Committee. - Patients undergoing kidney transplants for the first time will be considered for inclusion in the study and admission criteria. - In case of informed consent, patients will be introduced. - Patients are divided into two arms of treatment with vitamin C and placebo base on Permuted Block Randomization .

Inclusion criteria: The first kidney transplantation Deceased donor Recipient age 14 years and older Patient informed consent to enter the study Non-inclusion criteria: Hemochromatosis Documented hyperoxaluria Multi organ transplantation History of Fauvism Preemptive kidney transplantation Exclusion Criteria: Patient's dissatisfaction with the continuation of research after entering the study

- Patients in the treatment arm receive 70 mg/kg vitamin C (at least 3 grams) at last hour before transplant surgery. The calculated dose is diluted in 250 ml of sodium chloride solution (0.45%) and infused over an hour before the transplant. In the placebo group, placebo (a saline solution of similar volume) is prescribed at that time.

dialysis in the first week after transplantation

This is a randomized, double-blind randomized, placebo-controlled clinical trial. The conditions are subdivided by using Permuted Block Randomization method into foursquare blocks randomly in two groups receiving injected intravenous vitamin C or placebo.

The placebo group, which is serum half-saline alone, receives the same volume in comparison to the drug. Since the drug does not have color, half-saline serum is used with the same volume as placebo.

Data related to main outcomes of the study will be shared of deidentified IPD as SPSS file.

Data will become available three months after publishing the related article. Data will be available for one year.

Data will be available for people working in academic institution.

An agreement deal between Liver Transplantation research Center of Tehran University of Medical Sciences and people/institution who want to have access to data is needed.

The applicant should contact with Professor Simin Dashti-Khavidaki to get these documents or data files. The contact details of Simin Dashti-Khavidaki is: E-mail: dashtis@sina.tums.ac.ir Tel/FAx: 0098 21 66954709

Applicant request will be assessed in the meeting of Liver Transplantation Research Center of Tehran University of Medical Sciences and data will be provided for him/her within 2 months after application acceptance and agreement deal signing.