Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT05179434
Status:
UNKNOWN
Last Update Posted:
2022-01-24
First Post:
2021-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-reperfusion Injury
Sponsor:
West Kazakhstan Medical University
Organization:
Study Overview
Official Title:
A Randomized Clinical Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-Reperfusion Injury
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: