NCT02080117

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

March 4, 2014

Last Update Submit

April 24, 2017

Conditions

Deceased Donor Kidney TransplantationLiving Donor Kidney Transplantation

Keywords

kidney transplantationdelayed graft functioncreatininegraft survival

Outcome Measures

Primary Outcomes (1)

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

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

    during 7 days after transplantation

Secondary Outcomes (5)

  • 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

    during 48 hours 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

    during 24 hours after transplantation

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

    during one week after transplantation

Other Outcomes (4)

  • graft survival

    one month, six month, and one year after transplantation

  • Mortality

    one month, six month, and one year after transplantation

  • immediate graft function

    after eight days after transplantation

  • +1 more other outcomes

Study Arms (1)

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

Interventions

kidney transplantation, living or deceased donorPROCEDURE
patients who underwent kidney transplantation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Delayed Graft Function

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsOrgan TransplantationTransplantationSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 6, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

KR(1)