- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01879124
Resistive Index Measurements After Kidney Transplantation
Correlation Between Renal Vascular Resistive Index, Renal Allograft Histology and Outcome
연구 개요
상태
정황
상세 설명
Since March 2004, and as part of routine clinical practice, protocol renal allograft biopsies are routinely performed at implantation and at 3, 12 and 24 months after transplantation, in all patients who receive a kidney transplant at the University Hospitals Leuven, unless there is a medical contra-indication or patient refusal to undergo this procedure. The biopsies are scheduled using a dedicated Microsoft Access database ("Biopsy Database"), that is maintained on the central servers of the University Hospitals Leuven. Patients who have an unexplained change in renal allograft function, undergo additional clinically indicated indication biopsies. These biopsies are also recorded in the aforementioned Microsoft Access Database.
All clinical data, including pretransplant donor and recipient characteristics, and post-transplant follow-up data are directly stored and maintained in a prospectively collected electronic database (CCL database until 06/2012, transferred to the central KWS database in 2012). This electronic database is the only existing clinical database for these patients, and contains all clinical patient charts. No written records are collected.
All renal allograft biopsies will be rescored by a single renal pathologist according to the most recent Banff classification, blinded for the clinical parameters and timing of the biopsy. These rescoring data are directly entered in the dedicated Microsoft Access database ("Biopsy Database").
Just prior to performing a renal allograft biopsy with ultrasound guidance, and as part of the routine clinical procedure, duplex measurements are performed by the radiologist who will perform the biopsy. The peak systolic velocity (Vmax) and the minimal diastolic velocity (Vmin) are determined in each patient in two to three representative interlobar arteries. The resistive index is calculated as [1 - (V min/V max)]. This procedure is repeated at three different places in the kidney (lower, interpolar and upper pole). These data are directly entered in the central electronic clinical database system (KWS, see above).
All electronic data will be transferred to a SAS database at time of data extraction.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Leuven, 벨기에, 3000
- Universitaire Ziekenhuizen Leuven
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Single kidney transplantation
Exclusion Criteria:
None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Kidney transplant recipients
All de novo renal allograft recipients transplanted at the University Hospitals Leuven between March 2004 and October 2007
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Overall renal allograft survival
기간: 7 years after transplantation
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7 years after transplantation
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Death-censored graft survival
기간: 7 years after transplantation
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7 years after transplantation
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Patient survival
기간: 7 years after transplantation
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7 years after transplantation
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Reduction of 50% or more in the eGFR from the value measured at the time of ultrasonography
기간: 7 years after transplantation
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7 years after transplantation
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공동 작업자 및 조사자
수사관
- 수석 연구원: Maarten Naesens, MD PhD, Universitaire Ziekenhuizen KU Leuven
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .