Deceased Donor Kidney TransplantationNCT02080117
Adequate Definition of Delayed Graft Function in Living and Deceased Donor Kidney Transplantation
An observational study of Deceased Donor Kidney Transplantation and Living Donor Kidney Transplantation, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deceased Donor Kidney Transplantation, Living Donor Kidney Transplantation
- What is being tested?
- kidney transplantation, living or deceased donor
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who underwent living or deceased donor kidney transplantation between 2008 and 2013
Who may be able to join
- patients who underwent living or deceased donor kidney transplantation between 2008 and 2013
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- kidney transplantation, living or deceased donor
- Keywords
- kidney transplantation, delayed graft function, creatinine, graft survival
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kidney transplantation, living or deceased donorProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| patients who underwent kidney transplantation | patients who underwent living or deceased donor kidney transplantation between 2008 and 2013 Receives: Procedure: kidney transplantation, living or deceased donor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during 7 days after transplantation
Secondary outcomes (5)
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
Measured: during 24 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 serum creatinine decrease less than 10% during 48 hours after transplantation
Measured: during 48 hours after transplantation
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
Measured: 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
delayed graft function as defined by creatinine clearance less than 10 ml/min/1.73m2 during 24 hours after transplantation
Measured: during 24 hours after transplantation
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
Measured: during one week after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deceased Donor Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WonHo Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080117
- Sponsor's protocol ID
- 2013-12-089
- Status last verified
- Apr 2017
- First submitted
- 4 Mar 2014
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequate Definition of Delayed Graft Function in Living and Deceased Donor Kidney Transplantation
- ClinicalTrials.gov ID
- NCT02080117
- Acronym / sponsor ID
- 2013-12-089
- Keywords
- kidney transplantation, delayed graft function, creatinine, graft survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who underwent kidney transplantation | – | Procedure: kidney transplantation, living or deceased donorpatients who underwent living or deceased donor kidney transplantation between 2008 and 2013 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent living or deceased donor kidney transplantation between 2008 and 2013
Key inclusion criteria (1 listed)
- patients who underwent living or deceased donor kidney transplantation between 2008 and 2013
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kidney transplantation, living or deceased donor | Procedure or surgery | patients who underwent kidney transplantation |
Primary outcome
delayed graft function as defined by dialysis requirements within one week after transplantation
Time frame: during 7 days after transplantation
delayed graft function as defined by dialysis requirements within one week after transplantation
5 secondary outcomes
delayed graft function as defined by urine output less than1200 ml during first day after transplantation
Time frame: during 24 hours after transplantation
delayed graft function as defined by serum creatinine decrease less than 10% during 48 hours after transplantation
Time frame: during 48 hours after transplantation
delayed graft function as defined by creatinine greater than 2.5 mg/dL at ten days after transplantation
Time frame: 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
Time frame: during 24 hours after transplantation
delayed graft function as defined by creatinine did not decrease less than preoperative value
Time frame: during one week after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deceased Donor Kidney Transplantation and Living Donor Kidney Transplantation, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delayed graft function as defined by dialysis requirements within one week after transplantation (time frame: during 7 days after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.