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Study aim:
Clinical evaluation of Delayed graft function (DGF) after kidney transplantation between the vitamin C arm and the placebo
Design:
A double-blind, randomized clinical trial with a control group and a placebo group design of 50 patients
Settings and conduct:
- 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 .
Participants/Inclusion and exclusion criteria:
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
Intervention groups:
- 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.
Main outcome variables:
dialysis in the first week after transplantation