NCT01363687

Brief Summary

The purpose of this study is to investigate whether upper limb ischemic postconditioning can improve renal function and decrease ischemic-reperfusion injury in patients undergoing living donor kidney transplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

9 months

First QC Date

May 23, 2011

Last Update Submit

December 24, 2013

Conditions

Kidney TransplantationIschemic Reperfusion InjuryRemote Ischemic Postconditioning

Outcome Measures

Primary Outcomes (7)

  • renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    1 day before surgery

  • renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    at 2 h after declaming of renal artery

  • renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    at 6 h after declaming of renal artery

  • renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    at 12 h after declaming of renal artery

  • renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    at 24 h after declaming of renal artery

  • renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    at 48 h after declaming of renal artery

  • renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    at 72 h after declaming of renal artery

Secondary Outcomes (4)

  • Biomarkers of acute kidney injury

    before surgery and at 2, 6, 12 h after declaming of renal artery

  • Hemodynamic parameters

    before surgery and at 2, 6, 12, 24, 48, 72 h after declaming of renal artery

  • outcome of kidney transplantation

    at 72 h after declaming of renal artery

  • postoperative hospital stay

    at postoperative day 60

Study Arms (2)

Remote ischemic postconditioning group

EXPERIMENTAL

Recipients receive remote ischemic postconditioning after declamping of renal artery during kidney transplantation

Device: remote ischemic postconditioning

Control group

NO INTERVENTION

Patients who have a deflated cuff placed on the upper limb free of arteriovenous fistula during the surgery

Interventions

remote ischemic postconditioningDEVICE

Remote ischemic postconditioning consists of three 5-min cycles of upper limb ischemia, which was induced by an automated cuff-inflator placed on the upper limb free of arteriovenous fistula and inflated to 250 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.

Remote ischemic postconditioning group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects undergoing elective living donor kidney transplantation
  • subjects older than 20 yrs who can give written informed consent

You may not qualify if:

  • re-transplant recipients
  • those with peripheral vascular disease affecting the upper limbs free of arteriovenous fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Seoul Hospital, Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

  • Kim WH, Lee JH, Kim GS, Sim HY, Kim SJ. The effect of remote ischemic postconditioning on graft function in patients undergoing living donor kidney transplantation. Transplantation. 2014 Sep 15;98(5):529-36. doi: 10.1097/TP.0000000000000098.

    PMID: 24770616DERIVED

Study Officials

  • Jong Hwan Lee, M.D.,Ph.D.

    Samsung Medical Center

    STUDY DIRECTOR

  • Won Ho Kim, M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 23, 2011

First Posted

June 1, 2011

Study Start

August 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

December 25, 2013

Record last verified: 2013-12

Locations

KR(1)