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

NCT05179434 | Unknown DMC

• 1 other identifier: 116.23.11.2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation; Ischemic Reperfusion Injury; Reperfusion

Outcome Measures

Primary Outcomes (1)

• Renal graft and recipients survival

  Renal graft function quality and recipients survival

  3 months

Secondary Outcomes (3)

• Median serum creatinine levels

  1 months

• Median serum urea levels

  1 months

• Median glomerular filtration rate (GFR) levels

  1 month

Study Arms (2)

Retrograde graft reperfusion

EXPERIMENTAL

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

Procedure: Retrograde renal graft reperfusion

conventional antegrade perfusion

ACTIVE COMPARATOR

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

Procedure: Conventional antegrade renal graft reperfusion (without retrograde reperfusion)

Interventions

Retrograde renal graft reperfusion PROCEDURE

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

Also known as: Venous reperfusion

Retrograde graft reperfusion

Conventional antegrade renal graft reperfusion (without retrograde reperfusion) PROCEDURE

Conventional arterial antegrade renal graft reperfusion during the kidney transplant procedure

Also known as: Arterial reperfusion

conventional antegrade perfusion

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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%;

Sponsors & Collaborators

• West Kazakhstan Medical University: lead

Study Sites (1)

West Kazakhstan Medical University

Aktobe, 040017, Kazakhstan

RECRUITING

Related Publications (2)

• 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.

  PMID: 26786360 BACKGROUND

• 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.

  PMID: 27815464 BACKGROUND

Central Study Contacts

Myltykbay Rysmakhanov

CONTACT

+7 777 036 5690; mrtransplantolog@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-doctoral, Department of Surgery No 2, MD

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)