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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplantation; Ischemic Reperfusion Injury; Reperfusion
• Intervention / Treatment: Procedure: Retrograde renal graft reperfusion; Procedure: Conventional antegrade renal graft reperfusion (without retrograde 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Myltykbay Rysmakhanov; Phone Number: +7 777 036 5690; Email: mrtransplantolog@gmail.com

Study Locations

• Kazakhstan
  • Aktobe, Kazakhstan, 040017
    • Recruiting
    • West Kazakhstan Medical University
    • Contact: Myltykbay Rysmakhanov, MD; Phone Number: +7 777 036 5690; Email: mrtransplantolog@gmail.com
    • Contact: Aibolat Smagulov, MD; Phone Number: +7 778 869 6644; Email: smagulov.aibolat@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Retrograde graft reperfusion; Kidney transplantation with retrograde venous reperfusion of renal graft followed by arterial reperfusion	Procedure: Retrograde renal graft reperfusion; Retrograde venous reperfusion of the renal graft during the kidney transplant procedure with consequent arterial reperfusion; Other Names: Venous reperfusion
Active Comparator: conventional antegrade perfusion; Kidney transplantation with conventional arterial reperfusion of renal graft (without retrograde venous reperfusion)	Procedure: Conventional antegrade renal graft reperfusion (without retrograde reperfusion); Conventional arterial antegrade renal graft reperfusion during the kidney transplant procedure; Other Names: Arterial reperfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal graft and recipients survival	Renal graft function quality and recipients survival	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median serum creatinine levels	Normalization of creatinine levels in dynamics	1 months
Median serum urea levels	Normalization of serum urea levels in dynamics	1 months
Median glomerular filtration rate (GFR) levels	Normalization of glomerular filtration ratio (GFR) in dynamics	1 month

Collaborators and Investigators

• Sponsor: West Kazakhstan Medical University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Ischemia; Wounds and Injuries; Reperfusion Injury
• Other Study ID Numbers: 116.23.11.2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No