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

Living Donor Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080117
• Other study ID #: 2013-12-089
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: April 24, 2017
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Deceased Donor Kidney Transplantation
• Delayed Graft Function
• Living Donor Kidney Transplantation

Intervention

Procedure:
• kidney transplantation, living or deceased donor

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	graft survival	graft survival one month, six month, and one year after transplantation	one month, six month, and one year after transplantation
Other	Mortality	Mortality after one month, six month, and one year after transplantation	one month, six month, and one year after transplantation
Other	immediate graft function	immediate graft function after eight days after transplantation (defined as serum creatinine decrease less than 70% of preoperative value)	after eight days after transplantation
Other	slow graft function	slow graft function at eight days after transplantation (defined as serum creatinine greater than 70% of preoperative value)	at eight days after transplantation
Primary	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	delayed graft function as defined by urine output less than1200 ml during first day after transplantation	delayed graft function as defined by urine output less than1200 ml during first day after transplantation	during 24 hours after transplantation
Secondary	delayed graft function as defined by serum creatinine decrease less than 10% during 48 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
Secondary	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 greater than 2.5 mg/dL at ten days after transplantation	after ten days after transplantation
Secondary	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 clearance less than 10 ml/min/1.73m2 during 24 hours after transplantation	during 24 hours after transplantation
Secondary	delayed graft function as defined by creatinine did not decrease less than preoperative value	delayed graft function as defined by creatinine did not decrease less than preoperative value	during one week after transplantation