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Kidney TransplantationNCT01363687

The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation

A study testing remote ischemic postconditioning in people with Kidney Transplantation and Ischemic Reperfusion Injury, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years
What is being tested?
remote ischemic postconditioning
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
Aug 2011to May 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Seoul Hospital, Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

About this study

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.

Read the detailed description

Ischemic reperfusion injury after kidney transplantation is a common clinical problem associated with a high morbidity and mortality. To reduce the adverse effect of ischemic reperfusion injury after organ transplantation, various strategies including ischemic preconditioning or postconditioning. Remote ischemic postconditioning is one of such strategies where brief ischemic reperfusion injury of one organ protects other organs from sustained ischemic reperfusion injury. Remote ischemic postconditioning of the limb with a tourniquet is a safe and convenient method of postconditioning organs against ischemic reperfusion injury. However, the efficacy of remote ischemic postconditioning in patients undergoing living donor kidney transplantation needs to be established. Therefore, we investigate the efficacy of remote ischemic postconditioning of the upper limb with a tourniquet in recipients of kidney transplantation by measuring the markers of acute kidney injury.

Being tested
remote ischemic postconditioning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT01363687
Study groupRoleWhat they receive
Remote ischemic postconditioning groupExperimentalRecipients receive remote ischemic postconditioning after declamping of renal artery during kidney transplantation
Receives: Device: remote ischemic postconditioning
Control groupNo interventionPatients who have a deflated cuff placed on the upper limb free of arteriovenous fistula during the surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    Measured: 1 day before surgery

  2. renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    Measured: at 2 h after declaming of renal artery

  3. renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    Measured: at 6 h after declaming of renal artery

  4. renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    Measured: at 12 h after declaming of renal artery

  5. renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    Measured: at 24 h after declaming of renal artery

  6. renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    Measured: at 48 h after declaming of renal artery

  7. renal function of recipient after living-related kidney transplantation

    serum creatinine concentration and urine output

    Measured: at 72 h after declaming of renal artery

Secondary outcomes (4)

  1. Biomarkers of acute kidney injury

    biomarkers of acute kidney injury: Plasma cystatin-C, Urine IL-18, Urine Neutrophil gelatinase-associated lipocalin (NGAL)

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

  2. Hemodynamic parameters

    arterial blood pressure, heart rate, central venous pressure, pulse oximetry

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

  3. outcome of kidney transplantation

    number of acute rejection or number of delayed graft function

    Measured: at 72 h after declaming of renal artery

  4. postoperative hospital stay

    length of postoperative hospital stay (days)

    Measured: at postoperative day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01363687
Sponsor's protocol ID
2011-03-047
Status last verified
Dec 2013
First submitted
23 May 2011
Last updated
25 Dec 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24770616

Questions about this trial

What is this clinical trial studying?

A study testing remote ischemic postconditioning in people with Kidney Transplantation and Ischemic Reperfusion Injury, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

renal function of recipient after living-related kidney transplantation (time frame: 1 day before surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01363687, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2013.

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