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

Completed

• Conditions: Living Donor Kidney Transplantation; Deceased Donor Kidney Transplantation
• Interventions: Procedure: kidney transplantation, living or deceased donor

• Registration Number: NCT02080117
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients who underwent kidney transplantation	kidney transplantation, living or deceased donor	patients who underwent living or deceased donor kidney transplantation between 2008 and 2013

Primary Outcome Measures

Name	Time	Method
delayed graft function as defined by dialysis requirements within one week after transplantation	during 7 days after transplantation	delayed graft function as defined by dialysis requirements within one week after transplantation

Secondary Outcome Measures

Name	Time	Method
delayed graft function as defined by creatinine did not decrease less than preoperative value	during one week after transplantation	delayed graft function as defined by creatinine did not decrease less than preoperative value
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 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	during 48 hours after transplantation	delayed graft function as defined by serum creatinine decrease less than 10% during 48 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 clearance less than 10 ml/min/1.73m2 during 24 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 greater than 2.5 mg/dL at ten days after transplantation

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of