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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02080117
Enrollment
800
Registered
2014-03-06
Start date
2014-01-31
Completion date
2016-12-31
Last updated
2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deceased Donor Kidney Transplantation, Living Donor Kidney Transplantation

Keywords

kidney transplantation, delayed graft function, creatinine, graft survival

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.

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.

Interventions

PROCEDUREkidney transplantation, living or deceased donor

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
delayed graft function as defined by dialysis requirements within one week after transplantationduring 7 days after transplantationdelayed graft function as defined by dialysis requirements within one week after transplantation

Secondary

MeasureTime frameDescription
delayed graft function as defined by serum creatinine decrease less than 10% during 48 hours after transplantationduring 48 hours after transplantationdelayed graft function as defined by serum creatinine decrease less than 10% during 48 hours after transplantation
delayed graft function as defined by urine output less than1200 ml during first day after transplantationduring 24 hours after transplantationdelayed graft function as defined by urine output less than1200 ml during first day after transplantation
delayed graft function as defined by creatinine greater than 2.5 mg/dL at ten days after transplantationafter ten days after transplantationdelayed 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 transplantationduring 24 hours after transplantationdelayed 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 valueduring one week after transplantationdelayed graft function as defined by creatinine did not decrease less than preoperative value

Other

MeasureTime frameDescription
immediate graft functionafter eight days after transplantationimmediate graft function after eight days after transplantation (defined as serum creatinine decrease less than 70% of preoperative value)
slow graft functionat eight days after transplantationslow graft function at eight days after transplantation (defined as serum creatinine greater than 70% of preoperative value)
Mortalityone month, six month, and one year after transplantationMortality after one month, six month, and one year after transplantation
graft survivalone month, six month, and one year after transplantationgraft survival one month, six month, and one year after transplantation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026