A Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-reperfusion Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-03-01

Brief Summary

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To evaluate whether retrograde venous reperfusion of a renal graft before antegrade arterial reperfusion can reduce ischemic-reperfusion injury.

All registered eligible candidates for kidney transplant will be randomized to receive either:

* retrograde venous, then arterial reperfusion or
* antegrade arterial reperfusion.

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Detailed Description

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According to our hypothesis, retrograde venous reperfusion prevents and reduces the immediate and long-term effects of renal allograft ischemic-reperfusion injury.

For the study Chi-square method of sample size estimation with a=0,05, b=0,20 required a 14 subject per group.

The study will include 30 potential kidney recipients for both group aged 18-60 years who will receive kidney transplants. Only adult patients undergoing primary living donor kidney transplantation with standard three-component immunosuppression will be enrolled to the study.The main study group will consist of 15 patients with retrograde graft reperfusion, and control group - will include 15 kidney recipients with only conventional antegrade arterial reperfusion (without retrograde reperfusion).

Patients of the study group with standard kidney implantation surgery will undergo retrograde reperfusion through the renal vein after venous anastomosis. After the venous anastomosis of the graft, an arterial anastomosis is applied with the renal artery without tightening the suture to leave a lumen sufficient for the outflow of retrograde blood. Then the retrograde blood flow through the renal vein is started, venous blood fills the graft and flows through the renal artery through the lumen of the anastomosis in a volume of 80-100 ml. Retrograde blood collected for gas and lactate analysis at the beginning of reperfusion, at the first minute and at the fifth minute. Further, the sutures of the arterial anastomosis are tightened, and after tying, a typical antegrade reperfusion of the graft through the renal artery is performed.

Patients in the control group will undergo standard kidney implantation surgery with typical antegrade arterial reperfusion.

T-test and Mann-Whitney test will be used to compare the median of urea, creatinine levels in serum and glomerular filtration rate (GFR) on the 1st, 7th, 14th, 30th, 60th postoperative day.

Conditions

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Kidney Transplantation Ischemic Reperfusion Injury Reperfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Retrograde graft reperfusion

Kidney transplantation with retrograde venous reperfusion of renal graft followed by arterial reperfusion

Group Type EXPERIMENTAL

Retrograde renal graft reperfusion

Intervention Type PROCEDURE

Retrograde venous reperfusion of the renal graft during the kidney transplant procedure with consequent arterial reperfusion

conventional antegrade perfusion

Kidney transplantation with conventional arterial reperfusion of renal graft (without retrograde venous reperfusion)

Group Type ACTIVE_COMPARATOR

Conventional antegrade renal graft reperfusion (without retrograde reperfusion)

Intervention Type PROCEDURE

Conventional arterial antegrade renal graft reperfusion during the kidney transplant procedure

Interventions

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Retrograde renal graft reperfusion

Retrograde venous reperfusion of the renal graft during the kidney transplant procedure with consequent arterial reperfusion

Intervention Type PROCEDURE

Conventional antegrade renal graft reperfusion (without retrograde reperfusion)

Conventional arterial antegrade renal graft reperfusion during the kidney transplant procedure

Intervention Type PROCEDURE

Other Intervention Names

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Venous reperfusion Arterial reperfusion

Eligibility Criteria

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Inclusion Criteria

* patients with end-stage kidney disease who are ready for kidney transplantation;
* Panel reactive antibodies (PRA) less than 20%.
* informed consent to participate in the study.

Exclusion Criteria

* recipients preparing for combined organ transplantation;
* recipients with previously performed transplantation of another organ;
* recipients preparing for transplantation with a different immunosuppressive regimen;
* upcoming blood group incompatibility (AB0-i) transplant;
* PRA antibodies more than 20%;

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No