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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
WonHo Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02080117
First received: March 4, 2014
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Deceased Donor Kidney Transplantation
Living Donor Kidney Transplantation
Procedure: kidney transplantation, living or deceased donor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Adequate Definition of Delayed Graft Function in Living and Deceased Donor Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • delayed graft function as defined by dialysis requirements within one week after transplantation [ Time Frame: during 7 days after transplantation ] [ Designated as safety issue: Yes ]
    delayed graft function as defined by dialysis requirements within one week after transplantation


Secondary Outcome Measures:
  • delayed graft function as defined by urine output less than1200 ml during first day after transplantation [ Time Frame: during 24 hours after transplantation ] [ Designated as safety issue: Yes ]
    delayed graft function as defined by urine output less than1200 ml during first day 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 ] [ Designated as safety issue: Yes ]
    delayed graft function as defined by serum creatinine decrease less than 10% 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 ] [ Designated as safety issue: No ]
    delayed graft function as defined by creatinine greater than 2.5 mg/dL at 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 ] [ Designated as safety issue: Yes ]
    delayed graft function as defined by creatinine clearance less than 10 ml/min/1.73m2 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 ] [ Designated as safety issue: Yes ]
    delayed graft function as defined by creatinine did not decrease less than preoperative value


Other Outcome Measures:
  • graft survival [ Time Frame: one month, six month, and one year after transplantation ] [ Designated as safety issue: Yes ]
    graft survival one month, six month, and one year after transplantation

  • Mortality [ Time Frame: one month, six month, and one year after transplantation ] [ Designated as safety issue: Yes ]
    Mortality after one month, six month, and one year after transplantation

  • immediate graft function [ Time Frame: after eight days after transplantation ] [ Designated as safety issue: Yes ]
    immediate graft function after eight days after transplantation (defined as serum creatinine decrease less than 70% of preoperative value)

  • slow graft function [ Time Frame: at eight days after transplantation ] [ Designated as safety issue: Yes ]
    slow graft function at eight days after transplantation (defined as serum creatinine greater than 70% of preoperative value)


Estimated Enrollment: 800
Study Start Date: January 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02080117

Contacts
Contact: Won Ho Kim, MD 82-55-290-6072 wonhokim.ane@gmail.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Won Ho Kim, MD    82-2-3410-2470    wonhokim.ane@gmail.com   
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: WonHo Kim, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02080117     History of Changes
Other Study ID Numbers: 2013-12-089
Study First Received: March 4, 2014
Last Updated: June 19, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
kidney transplantation
delayed graft function
creatinine
graft survival

Additional relevant MeSH terms:
Death
Delayed Graft Function
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014