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IRCT20251231068512N1 IRCT 2026-01-13 Iran University of Medical Sciences The effect of intraoperative intravenous mannitol injection on delayed graft function in kidney transplant recipients. A comparative study of the effect of intravenous mannitol injection during surgery on the rate of delayed transplant performance in kidney transplant recipients in Hashminejad Hospital 2026-02-20 anticipated 120 Recruiting https://irct.ir/trial/88592 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization Method: Block randomization will be used. Patients will be allocated to either the intervention (mannitol) or control (placebo) group using the block randomization method. This approach ensures that the number of patients in the two groups remains approximately balanced throughout the study. Unit of Randomization: Individual (patient). Randomization Tool: Microsoft Excel with the RAND function will be used. Random Sequence Generation: To perform block randomization with a block size of 4 in Excel, all possible balanced permutations of two patients allocated to group "A" (e.g., mannitol) and two to group "B" (placebo) are first listed in a column. Next to each permutation, a random number is generated using the RAND function for each row. By sorting the entire list based on the column of random numbers (in ascending or descending order), the final sequence of blocks is determined randomly. This randomized sequence of consecutive 4‑patient blocks then forms the master allocation list. Allocation Concealment: To maintain concealment, the allocation list will be stored and implemented using serially numbered, opaque, sealed envelopes or a secure electronic system, Blinding description: This study is designed as a triple-blinded trial to prevent any bias in the intervention and outcome assessment. Patients will be unaware of their assignment to the intervention or control group, as the injected solutions (20% mannitol and 0.9% normal saline) will be identical in appearance, volume, and administration method, prepared in identical, unlabeled containers. The anesthesiologist administering the solution will also be blinded to its nature (active drug or placebo), since the preparation and coding of the solutions will be performed by an independent staff member not involved in the trial. Furthermore, the outcome assessor (who records and adjudicates endpoint data such as dialysis requirement, serum creatinine levels, and biopsy results) will remain blinded to the group allocation codes. The allocation sequence will be kept in serially numbered, opaque, sealed envelopes or a secure electronic system and will be disclosed only in the event of a medical emergency. 2-3 Kidney transplant. Intervention 1: Intervention group: the intervention group will receive a 20% Mannitol (D-Mannitol) solution intravenously during surgery. The drug dosage is calculated based on body weight (0.5 mL/kg, equivalent to 0.1 g/kg) and is capped at a maximum of 50 mL. The administration protocol involves the injection of a 10 mL bolus immediately before graft reperfusion, followed by continuous infusion of the remaining volume until the end of the procedure. Intervention 2: Control group: The control group will receive 0.9% sodium chloride (normal saline) as an active placebo. The dose, volume (based on 0.5 mL/kg, up to a maximum of 50 mL), and administration protocol (including a 10 mL bolus before graft reperfusion and continued infusion until the end of the procedure) will be exactly the same as for the mannitol group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Saber Khoramabadi
Vali Asr Street (AJ), above Vanak Square, Shahid Valinejad Alley, Shahid Hashminejad Hospital, Tehran
Tehran Iran (Islamic Republic of) 1969714713 +98 21 81161 Drsaberkhorramabadi@gmail.com Iran University of Medical Sciences scientific Saber Khoramabadi
Vali Asr Street (AJ), above Vanak Square, Shahid Valinejad Alley, Shahid Hashminejad Hospital, Tehran
Tehran Iran (Islamic Republic of) 1969714713 +98 21 81161 Drsaberkhorramabadi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) First-time kidney transplant recipient Age 18–70 years Surgery within the study period Multidisciplinary team approval (Psychiatry, Nephrology, Surgery) Transplant benefits outweigh risks Tolerates surgery and immunosuppression 18 years 70 years Both Underwent renal autotransplantation Known hypersensitivity to mannitol Any adverse reaction that cannot be controlled during the study T86.12 Kidney transplant failure Other Placebo Intervention group: the intervention group will receive a 20% Mannitol (D-Mannitol) solution intravenously during surgery. The drug dosage is calculated based on body weight (0.5 mL/kg, equivalent to 0.1 g/kg) and is capped at a maximum of 50 mL. The administration protocol involves the injection of a 10 mL bolus immediately before graft reperfusion, followed by continuous infusion of the remaining volume until the end of the procedure. Control group: The control group will receive 0.9% sodium chloride (normal saline) as an active placebo. The dose, volume (based on 0.5 mL/kg, up to a maximum of 50 mL), and administration protocol (including a 10 mL bolus before graft reperfusion and continued infusion until the end of the procedure) will be exactly the same as for the mannitol group. Delayed Graft Function. Timepoint: 10 days post-transplant. Method of measurement: Clinical examination. Serum creatinine level. Timepoint: Up to 10 days after transplantation. Method of measurement: Test. 24-hour urine volume. Timepoint: 24 hours after receiving the transplant. Method of measurement: Test. Deaths. Timepoint: Up to 3 months after transplantation. Method of measurement: Follow-up. Cold ischemic time. Timepoint: During the transplant operation. Method of measurement: observation. Warm Ischemic Time. Timepoint: During the transplant operation. Method of measurement: observation. Iran University of Medical Sciences Approved 2025-07-22 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)