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

This study has been completed.
Sponsor:
Collaborator:
B. Braun Medical SA
Information provided by (Responsible Party):
Hua Zheng, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01289548
First received: February 2, 2011
Last updated: July 8, 2013
Last verified: September 2012
Results First Received: September 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Kidney Diseases
Kidney Failure, Chronic
Kidney Failure
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Intervention: Device: remote ischaemic preconditioning

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients scheduled for living donor renal transplantation in the Department of Transplantation, Tongji Hospital, Huazhong University of Science and Technology were recruited in the project from May 2010 to November 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
68 pairs of patients were enrolled during the recruitment period. among them, 5 recipients had the history of renal transplantation before; 2 recipients had concomitant diabetes mellitus; and another one recipient had severe varicose vein in his lower limb. The left 60 pairs of donors and recipients (120 in total) were finally assigned to groups.

Reporting Groups
  Description
Control patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min
Donor RIPC 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.
Recipient PIPC 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.

Participant Flow:   Overall Study
    Control     Donor RIPC     Recipient PIPC  
STARTED     40 [1]   40 [1]   40 [1]
Donors     20     20     20  
Recipients     20     20     20  
COMPLETED     40     40     40  
NOT COMPLETED     0     0     0  
[1] include both donors and recipients listed as milestones below



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
Donor + RIPC 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.
Recipient +RIPC 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.
Total Total of all reporting groups

Baseline Measures
    Control     Donor + RIPC     Recipient +RIPC     Total  
Number of Participants  
[units: participants]
  20     20     20     60  
Age [1]
[units: years]
Mean ± Standard Deviation
  32.5  ± 10.3     28.1  ± 6.5     30.6  ± 7.0     30.4  ± 8.2  
Age [2]
[units: years]
Mean ± Standard Deviation
  46.9  ± 6.4     47.4  ± 10.0     48.7  ± 5.2     47.6  ± 7.4  
Gender [3]
[units: participants]
       
Female     4     4     6     14  
Male     16     16     14     46  
Gender [4]
[units: participants]
       
Female     12     14     10     36  
Male     8     6     10     24  
Region of Enrollment  
[units: donors/recipients┬ápairs]
       
China     20     20     20     60  
Body mass index (BMI) [5]
[units: kg/m^2]
Mean ± Standard Deviation
  20.08  ± 2.75     19.94  ± 1.99     20.38  ± 3.20     20.13  ± 2.65  
Cold ischemic time [6]
[units: minutes]
Mean ± Standard Deviation
  175.65  ± 36.35     166.25  ± 19.22     177.25  ± 27.59     173.05  ± 28.52  
Body mass index (BMI) [7]
[units: kg/m^2]
Mean ± Standard Deviation
  22.19  ± 3.51     22.19  ± 2.43     23.45  ± 2.61     22.61  ± 2.90  
Relationship [8]
[units: donors/recipients┬ápairs]
       
parents     12     16     14     42  
siblings     6     2     5     13  
spouses     2     2     1     5  
[1] Age of the recipient
[2] Age of the donor
[3] Gender of the recipient
[4] Gender of the donor
[5] BMI of the recipient. BMI=weight(kg)/〖height(m)〗^2
[6] Time from fully perfusion of the donor kidney to complement of the artery unclamping in the transplantation surgery
[7] BMI of the donor. BMI=weight(kg)/〖height(m)〗^2
[8] The donor's relationship with the recipient



  Outcome Measures
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1.  Primary:   Plasma Creatine Concentration of the Recipients   [ Time Frame: within the first 3days after the operation ]

2.  Primary:   Urinary Output of the Recipients Postoperatively   [ Time Frame: within the first 3days after the operation ]

3.  Primary:   Plasma Concentration of NGAL in the Recipients   [ Time Frame: within the first 24hours after the operation ]

4.  Secondary:   Acute Rejection of Transplanted Kidney   [ Time Frame: before discharge ]

5.  Secondary:   Delayed Graft Function   [ Time Frame: before discharge ]

6.  Secondary:   Length of Postoperative Hospital Stay   [ Time Frame: before discharge ]

7.  Secondary:   Total Costs During the Hospitalization   [ Time Frame: from the admission to the discharge of the patients ]

8.  Secondary:   Urine Concentration of NAG Preoperatively in Recipients   [ Time Frame: before operation ]

9.  Secondary:   Urine Concentration of NAG Postoperatively in Recipients   [ Time Frame: within the first 24hours after the artery unclamping ]

10.  Secondary:   Urine Concentration of RBP Preoperatively in the Recipients   [ Time Frame: before the operation ]

11.  Secondary:   Urine Concentration of RBP Postoperatively in the Recipients   [ Time Frame: within the first 24hours after the artery unclamping ]

12.  Secondary:   Plasma Concentration of SOD in the Recipients   [ Time Frame: within 24hours after the operation ]

13.  Secondary:   Plasma Concentration of MDA in the Recipients   [ Time Frame: within the first 24hours after the operation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The trial was conducted only in our hospital and had a relatively small sample size because of the scarcity of relative living donor renal transplantation compared to other surgeries.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Hua zheng
Organization: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
phone: 00862783663173
e-mail: huaz1980@hotmail.com


No publications provided by Huazhong University of Science and Technology

Publications automatically indexed to this study:

Responsible Party: Hua Zheng, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01289548     History of Changes
Other Study ID Numbers: TJMZK201001
Study First Received: February 2, 2011
Results First Received: September 5, 2012
Last Updated: July 8, 2013
Health Authority: China: Ministry of Health