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

April 24, 2017 updated by: WonHo Kim, Samsung Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients who underwent kidney transplantation
patients who underwent living or deceased donor kidney transplantation between 2008 and 2013
Procedure: kidney transplantation, living or deceased donor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during 7 days after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during 24 hours after transplantation
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
during 48 hours after transplantation
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
after ten days after transplantation
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
during 24 hours after transplantation
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
during one week after transplantation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
graft survival
Time Frame: one month, six month, and one year after transplantation
graft survival one month, six month, and one year after transplantation
one month, six month, and one year after transplantation
Mortality
Time Frame: one month, six month, and one year after transplantation
Mortality after one month, six month, and one year after transplantation
one month, six month, and one year after transplantation
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)
after eight days after transplantation
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)
at eight days after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-12-089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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