Clinical trial NCT02080117: Adequate Definition of Delayed Graft Function in Living and Deceased Donor Kidney Transplantation
Official title: Adequate Definition of Delayed Graft Function in Living and Deceased Donor Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deceased Donor Kidney Transplantation
Living Donor Kidney Transplantation
Keywords: kidney transplantation
delayed graft function
creatinine
graft survival
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent living or deceased donor kidney transplantation between 2008 and 2013

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.

Eligibility 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

Primary outcomes:
measure: delayed graft function as defined by dialysis requirements within one week after transplantation
timeFrame: during 7 days after transplantation
Secondary outcomes:
measure: delayed graft function as defined by urine output less than1200 ml during first day after transplantation
timeFrame: during 24 hours after transplantation
measure: delayed graft function as defined by serum creatinine decrease less than 10% during 48 hours after transplantation
timeFrame: during 48 hours after transplantation
measure: delayed graft function as defined by creatinine greater than 2.5 mg/dL at ten days after transplantation
timeFrame: after ten days after transplantation
measure: delayed graft function as defined by creatinine clearance less than 10 ml/min/1.73m2 during 24 hours after transplantation
timeFrame: during 24 hours after transplantation
measure: delayed graft function as defined by creatinine did not decrease less than preoperative value
timeFrame: during one week after transplantation
Other outcomes:
measure: graft survival
timeFrame: one month, six month, and one year after transplantation
measure: Mortality
timeFrame: one month, six month, and one year after transplantation
measure: immediate graft function
timeFrame: after eight days after transplantation
measure: slow graft function
timeFrame: at eight days after transplantation
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: