Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation
Effect of Lower Limb Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 2, 2011
CompletedFirst Posted
Study publicly available on registry
February 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
September 10, 2013
CompletedSeptember 10, 2013
September 1, 2012
1.5 years
February 2, 2011
September 5, 2012
July 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Plasma Creatine Concentration of the Recipients
Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping
within the first 3days after the operation
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
within the first 3days 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
within the first 24hours after the operation
Secondary Outcomes (10)
Acute Rejection of Transplanted Kidney
before discharge
Delayed Graft Function
before discharge
Length of Postoperative Hospital Stay
before discharge
Total Costs During the Hospitalization
from the admission to the discharge of the patients
Urine Concentration of NAG Preoperatively in Recipients
before operation
- +5 more secondary outcomes
Study Arms (3)
control
NO INTERVENTIONpatients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min
donor
EXPERIMENTALDonors 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
EXPERIMENTALrecipients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- Re-transplant patients
- Those with peripheral vascular disease affecting the lower limbs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huazhong University of Science and Technologylead
- B. Braun Medical SAcollaborator
Study Sites (1)
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Related Publications (1)
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.
PMID: 23325011DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Hua zheng
- Organization
- Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Study Officials
- STUDY CHAIR
Yuke Tian, M.D.
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Study Record Dates
First Submitted
February 2, 2011
First Posted
February 3, 2011
Study Start
May 1, 2010
Primary Completion
November 1, 2011
Study Completion
January 1, 2012
Last Updated
September 10, 2013
Results First Posted
September 10, 2013
Record last verified: 2012-09