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Completed

NCT Number: NCT01363687

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

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.

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Key information

Conditions

Kidney Transplantation Ischemic Reperfusion Injury Remote Ischemic Postconditioning

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Seoul Hospital, Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

remote ischemic postconditioning

Device

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.

Primary outcomes

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

    Time frame: 1 day before surgery

    serum creatinine concentration and urine output

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

    Time frame: at 2 h after declaming of renal artery

    serum creatinine concentration and urine output

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

    Time frame: at 6 h after declaming of renal artery

    serum creatinine concentration and urine output

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

    Time frame: at 12 h after declaming of renal artery

    serum creatinine concentration and urine output

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

    Time frame: at 24 h after declaming of renal artery

    serum creatinine concentration and urine output

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

    Time frame: at 48 h after declaming of renal artery

    serum creatinine concentration and urine output

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

    Time frame: at 72 h after declaming of renal artery

    serum creatinine concentration and urine output

Secondary outcomes

  1. Biomarkers of acute kidney injury

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

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

  2. Hemodynamic parameters

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

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

  3. outcome of kidney transplantation

    Time frame: at 72 h after declaming of renal artery

    number of acute rejection or number of delayed graft function

  4. postoperative hospital stay

    Time frame: at postoperative day 60

    length of postoperative hospital stay (days)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 1, 2011
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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