A Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-reperfusion Injury
Primary Purpose
Kidney Transplantation, Ischemic Reperfusion Injury, Reperfusion
Status
Recruiting
Phase
Not Applicable
Locations
Kazakhstan
Study Type
Interventional
Intervention
Retrograde renal graft reperfusion
Conventional antegrade renal graft reperfusion (without retrograde reperfusion)
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Transplantation
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%;
Sites / Locations
- West Kazakhstan Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Retrograde graft reperfusion
conventional antegrade perfusion
Arm Description
Kidney transplantation with retrograde venous reperfusion of renal graft followed by arterial reperfusion
Kidney transplantation with conventional arterial reperfusion of renal graft (without retrograde venous reperfusion)
Outcomes
Primary Outcome Measures
Renal graft and recipients survival
Renal graft function quality and recipients survival
Secondary Outcome Measures
Median serum creatinine levels
Normalization of creatinine levels in dynamics
Median serum urea levels
Normalization of serum urea levels in dynamics
Median glomerular filtration rate (GFR) levels
Normalization of glomerular filtration ratio (GFR) in dynamics
Full Information
NCT ID
NCT05179434
First Posted
December 16, 2021
Last Updated
January 6, 2022
Sponsor
West Kazakhstan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05179434
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Kazakhstan Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Ischemic Reperfusion Injury, Reperfusion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Retrograde graft reperfusion
Arm Type
Experimental
Arm Description
Kidney transplantation with retrograde venous reperfusion of renal graft followed by arterial reperfusion
Arm Title
conventional antegrade perfusion
Arm Type
Active Comparator
Arm Description
Kidney transplantation with conventional arterial reperfusion of renal graft (without retrograde venous reperfusion)
Intervention Type
Procedure
Intervention Name(s)
Retrograde renal graft reperfusion
Other Intervention Name(s)
Venous reperfusion
Intervention Description
Retrograde venous reperfusion of the renal graft during the kidney transplant procedure with consequent arterial reperfusion
Intervention Type
Procedure
Intervention Name(s)
Conventional antegrade renal graft reperfusion (without retrograde reperfusion)
Other Intervention Name(s)
Arterial reperfusion
Intervention Description
Conventional arterial antegrade renal graft reperfusion during the kidney transplant procedure
Primary Outcome Measure Information:
Title
Renal graft and recipients survival
Description
Renal graft function quality and recipients survival
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Median serum creatinine levels
Description
Normalization of creatinine levels in dynamics
Time Frame
1 months
Title
Median serum urea levels
Description
Normalization of serum urea levels in dynamics
Time Frame
1 months
Title
Median glomerular filtration rate (GFR) levels
Description
Normalization of glomerular filtration ratio (GFR) in dynamics
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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%;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myltykbay Rysmakhanov
Phone
+7 777 036 5690
Email
mrtransplantolog@gmail.com
Facility Information:
Facility Name
West Kazakhstan Medical University
City
Aktobe
ZIP/Postal Code
040017
Country
Kazakhstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myltykbay Rysmakhanov, MD
Phone
+7 777 036 5690
Email
mrtransplantolog@gmail.com
First Name & Middle Initial & Last Name & Degree
Aibolat Smagulov, MD
Phone
+7 778 869 6644
Email
smagulov.aibolat@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26786360
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.
Results Reference
background
PubMed Identifier
27815464
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.
Results Reference
background
Learn more about this trial
A Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-reperfusion Injury
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