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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05179434
Enrollment
30
Registered
2022-01-05
Start date
2020-12-01
Completion date
2023-03-01
Last updated
2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Reperfusion Injury, Kidney Transplantation, Reperfusion

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURERetrograde renal graft reperfusion

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

PROCEDUREConventional antegrade renal graft reperfusion (without retrograde reperfusion)

Conventional arterial antegrade renal graft reperfusion during the kidney transplant procedure

Sponsors

West Kazakhstan Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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%;

Design outcomes

Primary

MeasureTime frameDescription
Renal graft and recipients survival3 monthsRenal graft function quality and recipients survival

Secondary

MeasureTime frameDescription
Median serum creatinine levels1 monthsNormalization of creatinine levels in dynamics
Median serum urea levels1 monthsNormalization of serum urea levels in dynamics
Median glomerular filtration rate (GFR) levels1 monthNormalization of glomerular filtration ratio (GFR) in dynamics

Countries

Kazakhstan

Contacts

Primary ContactMyltykbay Rysmakhanov
mrtransplantolog@gmail.com+7 777 036 5690

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026