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Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation

Primary Purpose

Kidney Diseases, Kidney Failure, Chronic, Kidney Failure

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remote ischaemic preconditioning
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Diseases focused on measuring remote ischaemic preconditioning, kidney transplantation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation
  • Living donors
  • Compatible ABO blood type
  • PRA < 20%

Exclusion Criteria:

  • Re-transplant patients
  • Those with peripheral vascular disease affecting the lower limbs

Sites / Locations

  • Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control

donor

recipient

Arm Description

patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min

Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.

recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.

Outcomes

Primary Outcome Measures

Plasma Creatine Concentration of the Recipients
Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping
Urinary Output of the Recipients Postoperatively
Accumulated urinary output 1hour, 4hours and 24hours after the artery unclamping and the urinary output on the 2nd and 3rd day after the operation
Plasma Concentration of NGAL in the Recipients
Plasma concentration of neutrophil gelatinase-associated lipocalin (NGAL) before the operation and 24hours after the artery unclamping

Secondary Outcome Measures

Acute Rejection of Transplanted Kidney
biopsy-confirmed, clinically symptomatic
Delayed Graft Function
Delayed Graft Function according to the clinical symptoms
Length of Postoperative Hospital Stay
time from the day of operation to the day of discharge for the recipients
Total Costs During the Hospitalization
Total costs from the admission to the discharge of the recipients
Urine Concentration of NAG Preoperatively in Recipients
Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation
Urine Concentration of NAG Postoperatively in Recipients
Urine concentration of N-acetyl-D-glucosaminidase (NAG) 1hour, 4hours and 24hours after the artery unclamping in the recipients
Urine Concentration of RBP Preoperatively in the Recipients
Urine concentration of retinol binding protein (RBP) before the operation in the recipients
Urine Concentration of RBP Postoperatively in the Recipients
Urine concentration of retinol binding protein (RBP) 1hour, 4hours and 24hours after the artery unclamping in the recipients
Plasma Concentration of SOD in the Recipients
Plasma concentration of superoxide dismutase (SOD) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients
Plasma Concentration of MDA in the Recipients
Plasma concentration of malondialdehyde (MDA) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients

Full Information

First Posted
February 2, 2011
Last Updated
July 8, 2013
Sponsor
Huazhong University of Science and Technology
Collaborators
B. Braun Medical SA
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1. Study Identification

Unique Protocol Identification Number
NCT01289548
Brief Title
Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation
Official Title
Effect of Lower Limb Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
Collaborators
B. Braun Medical SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation
Detailed Description
Ischemia reperfusion injury (IRI) induced renal failure after kidney transplantation is a common clinical problem associated with a high morbidity and mortality. To reduce the adverse effects of IRI after organ transplantation various strategies aimed at the different pathophysiological processes of IRI have been investigated. Remote ischemic preconditioning (RIPC) is one such strategy where brief IRI of one organ protects other organs from sustained IRI. Many studies have shown that RIPC protects heart, muscle flaps, stomach, liver, lungs, and kidneys from IRI. RIPC of the limb with a tourniquet is a safe and convenient method of preconditioning organs against IRI. However, the efficacy of RIPC in patients undergoing living donor kidney transplantation need to be established and mechanism of early and late RIPC, such as whether the donor should undergo remote preconditioning or the recipient, need to be investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Kidney Failure, Chronic, Kidney Failure, Renal Insufficiency, Renal Insufficiency, Chronic, Urologic Diseases
Keywords
remote ischaemic preconditioning, kidney transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min
Arm Title
donor
Arm Type
Experimental
Arm Description
Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
Arm Title
recipient
Arm Type
Experimental
Arm Description
recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
Intervention Type
Device
Intervention Name(s)
remote ischaemic preconditioning
Other Intervention Name(s)
RIPC
Intervention Description
Remote ischaemic preconditioning consisted of three 5-min cycles of left lower limb ischaemia, which was induced by an automated cuff-inflator placed on the left lower limb and inflated to 300 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
Primary Outcome Measure Information:
Title
Plasma Creatine Concentration of the Recipients
Description
Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping
Time Frame
within the first 3days after the operation
Title
Urinary Output of the Recipients Postoperatively
Description
Accumulated urinary output 1hour, 4hours and 24hours after the artery unclamping and the urinary output on the 2nd and 3rd day after the operation
Time Frame
within the first 3days after the operation
Title
Plasma Concentration of NGAL in the Recipients
Description
Plasma concentration of neutrophil gelatinase-associated lipocalin (NGAL) before the operation and 24hours after the artery unclamping
Time Frame
within the first 24hours after the operation
Secondary Outcome Measure Information:
Title
Acute Rejection of Transplanted Kidney
Description
biopsy-confirmed, clinically symptomatic
Time Frame
before discharge
Title
Delayed Graft Function
Description
Delayed Graft Function according to the clinical symptoms
Time Frame
before discharge
Title
Length of Postoperative Hospital Stay
Description
time from the day of operation to the day of discharge for the recipients
Time Frame
before discharge
Title
Total Costs During the Hospitalization
Description
Total costs from the admission to the discharge of the recipients
Time Frame
from the admission to the discharge of the patients
Title
Urine Concentration of NAG Preoperatively in Recipients
Description
Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation
Time Frame
before operation
Title
Urine Concentration of NAG Postoperatively in Recipients
Description
Urine concentration of N-acetyl-D-glucosaminidase (NAG) 1hour, 4hours and 24hours after the artery unclamping in the recipients
Time Frame
within the first 24hours after the artery unclamping
Title
Urine Concentration of RBP Preoperatively in the Recipients
Description
Urine concentration of retinol binding protein (RBP) before the operation in the recipients
Time Frame
before the operation
Title
Urine Concentration of RBP Postoperatively in the Recipients
Description
Urine concentration of retinol binding protein (RBP) 1hour, 4hours and 24hours after the artery unclamping in the recipients
Time Frame
within the first 24hours after the artery unclamping
Title
Plasma Concentration of SOD in the Recipients
Description
Plasma concentration of superoxide dismutase (SOD) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients
Time Frame
within 24hours after the operation
Title
Plasma Concentration of MDA in the Recipients
Description
Plasma concentration of malondialdehyde (MDA) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients
Time Frame
within the first 24hours after the operation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation Living donors Compatible ABO blood type PRA < 20% Exclusion Criteria: Re-transplant patients Those with peripheral vascular disease affecting the lower limbs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuke Tian, M.D.
Organizational Affiliation
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23325011
Citation
Chen Y, Zheng H, Wang X, Zhou Z, Luo A, Tian Y. Remote ischemic preconditioning fails to improve early renal function of patients undergoing living-donor renal transplantation: a randomized controlled trial. Transplantation. 2013 Jan 27;95(2):e4-6. doi: 10.1097/TP.0b013e3182782f3a. No abstract available.
Results Reference
derived

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Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation

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