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NCT Number: NCT02080117

Adequate Definition of Delayed Graft Function in Living and Deceased Donor Kidney Transplantation

It is required to establish an adequate definition of delayed graft function in deceased donor kidney transplantation. We attempt to compare various definitions of delayed graft function and find the definition that can predict graft function survival best in deceased donor kidney transplantation.

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Key information

Conditions

Deceased Donor Kidney Transplantation Delayed Graft Function Living Donor Kidney Transplantation Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

Delayed graft function after kidney transplantation has been reported to be an important predictor for poor short and long-term survival. Delayed graft function increases post-transplantation morbidity, hospital stay, and incidence of premature graft failure. However, the definition of delayed graft function varies and more than ten definitions have been used in previous studies. Although the definition using dialysis requirements during seven days after transplantation has been used most frequently, dialysis may be required without any evidence of renal damage during one week after transplantation. Furthermore, the incidence of delayed graft function in living donor kidney transplantation using this definition has been reported to be relatively low (as low as 1.6%) compared with the incidence in deceased donor kidney transplantation (up to 50%). Therefore, it is required to establish a better definition of delayed graft function in deceased donor kidney transplantation. We attempt to compare various definitions of delayed graft function in deceased donor kidney transplantation and find the definition that can predict graft function survival best in deceased donor kidney transplantation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients who underwent living or deceased donor kidney transplantation between 2008 and 2013

Exclusion criteria

  • incomplete data of postoperative creatinine during ten days after transplantation or postoperative urine output during three days after transplantation
  • patients who underwent retransplantation
  • patients who expired for reasons other than kidney transplantation

Treatment and study plan

kidney transplantation, living or deceased donor

Procedure

Primary outcomes

  1. delayed graft function as defined by dialysis requirements within one week after transplantation

    Time frame: during 7 days after transplantation

    delayed graft function as defined by dialysis requirements within one week after transplantation

Secondary outcomes

  1. delayed graft function as defined by urine output less than1200 ml during first day after transplantation

    Time frame: during 24 hours after transplantation

    delayed graft function as defined by urine output less than1200 ml during first day after transplantation

  2. delayed graft function as defined by serum creatinine decrease less than 10% during 48 hours after transplantation

    Time frame: during 48 hours after transplantation

    delayed graft function as defined by serum creatinine decrease less than 10% during 48 hours after transplantation

  3. delayed graft function as defined by creatinine greater than 2.5 mg/dL at ten days after transplantation

    Time frame: after ten days after transplantation

    delayed graft function as defined by creatinine greater than 2.5 mg/dL at ten days after transplantation

  4. delayed graft function as defined by creatinine clearance less than 10 ml/min/1.73m2 during 24 hours after transplantation

    Time frame: during 24 hours after transplantation

    delayed graft function as defined by creatinine clearance less than 10 ml/min/1.73m2 during 24 hours after transplantation

  5. delayed graft function as defined by creatinine did not decrease less than preoperative value

    Time frame: during one week after transplantation

    delayed graft function as defined by creatinine did not decrease less than preoperative value

Other outcomes

  1. graft survival

    Time frame: one month, six month, and one year after transplantation

    graft survival one month, six month, and one year after transplantation

  2. Mortality

    Time frame: one month, six month, and one year after transplantation

    Mortality after one month, six month, and one year after transplantation

  3. immediate graft function

    Time frame: after eight days after transplantation

    immediate graft function after eight days after transplantation (defined as serum creatinine decrease less than 70% of preoperative value)

  4. slow graft function

    Time frame: at eight days after transplantation

    slow graft function at eight days after transplantation (defined as serum creatinine greater than 70% of preoperative value)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 6, 2014
Registry last updated
Apr 25, 2017

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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