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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179434
• Other study ID #: 116.23.11.2020
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: January 2022
• Source: West Kazakhstan Medical University
• Contact: Myltykbay Rysmakhanov
• Phone: +7 777 036 5690
• Email: mrtransplantolog[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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%;

Related Conditions & MeSH terms

• Ischemia
• Ischemic Reperfusion Injury
• Kidney Transplantation
• Reperfusion
• Reperfusion Injury
• Wounds and Injuries

Intervention

Procedure:
• Retrograde renal graft reperfusion
Retrograde venous reperfusion of the renal graft during the kidney transplant procedure with consequent arterial reperfusion
• Conventional antegrade renal graft reperfusion (without retrograde reperfusion)
Conventional arterial antegrade renal graft reperfusion during the kidney transplant procedure

Locations

Country	Name	City	State
Kazakhstan	West Kazakhstan Medical University	Aktobe

Sponsors (1)

Lead Sponsor	Collaborator
West Kazakhstan Medical University

Country where clinical trial is conducted

Kazakhstan, 

References & Publications (2)

Molácek J, Opatrný V, Matejka R, Baxa J, Treška V. Retrograde Oxygen Persufflation of Kidney - Experiment on an Animal. In Vivo. 2016 11-12;30(6):801-805. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal graft and recipients survival	Renal graft function quality and recipients survival	3 months
Secondary	Median serum creatinine levels	Normalization of creatinine levels in dynamics	1 months
Secondary	Median serum urea levels	Normalization of serum urea levels in dynamics	1 months
Secondary	Median glomerular filtration rate (GFR) levels	Normalization of glomerular filtration ratio (GFR) in dynamics	1 month