Clinical trial NCT05179434: A Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-reperfusion Injury
Official title: A Randomized Clinical Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-Reperfusion Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplantation
Ischemic Reperfusion Injury
Reperfusion
Lead sponsor: West Kazakhstan Medical University
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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%;

Primary outcomes:
measure: Renal graft and recipients survival
timeFrame: 3 months
Secondary outcomes:
measure: Median serum creatinine levels
timeFrame: 1 months
measure: Median serum urea levels
timeFrame: 1 months
measure: Median glomerular filtration rate (GFR) levels
timeFrame: 1 month
Other outcomes:
Locations:
city: Aktobe
country: Kazakhstan
facility: West Kazakhstan Medical University
Study officials:
References:
citation: Tasoulis MK, Douzinas EE. Hypoxemic reperfusion of ischemic states: an alternative approach for the attenuation of oxidative stress mediated reperfusion injury. J Biomed Sci. 2016 Jan 19;23:7. doi: 10.1186/s12929-016-0220-0.
citation: Molacek J, Opatrny V, Matejka R, Baxa J, Treska V. Retrograde Oxygen Persufflation of Kidney - Experiment on an Animal. In Vivo. 2016 11-12;30(6):801-805. doi: 10.21873/invivo.10997.