- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00179192
Prevention and Treatment of Hemodialysis Vascular Access Malfunction
Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the US of at least one billion dollars annually. Currently, complication free survival of vascular access ranges between 30-50% a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses.
It is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access. Moreover, once accesses at potential risk are identified, it is not well established which method of intervention, Surgery vs. Angioplasty vs. Expectant Management, is superior in terms of clinical and financial outcome. The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and, specifically, which means of intervention is preferred.
연구 개요
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
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Tennessee
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Nashville, Tennessee, 미국, 37232
- Vanderbilt University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subjects with End Stage Renal Disease on chronic maintenance hemodialysis 3 times per week
- Have an arteriovenous (polytetrafluoroethylene) graft as vascular access
- Have a venous stenosis between 30% and 70% as determined by angiogram
Exclusion Criteria:
- Native arteriovenous fistula
- Known previous vascular accesses complications, such as central vein stenosis, and multiple access surgeries >4
- Unwilling to participate
- Allergy to iodine
- Absolute contraindication for surgery (e.g. medical condition precludes anesthesia and surgery)
- Known arterial limb stenosis or long vessel length venous stenosis which are unamenable to surgical or angioplasty techniques, respectively, and therefore prohibit randomization
- Known hypercoagulable state
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 1
control group
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활성 비교기: 2
angioplasty intervention
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angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist
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활성 비교기: 3
surgery intervention
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surgical revision of patient's PTFE in a timely fashion not to exceed 72-96 hours after the angiogram; method of revision to be determined by the surgeon performing the procedure
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
To test the hypothesis that early intervention of a vascular access determined to be at increased risk of malfunction and thrombosis improves the long-term access outcome versus standard of care.
기간: 2 years
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2 years
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2차 결과 측정
결과 측정 |
기간 |
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To determine which means of early intervention, surgery versus angioplasty, is medically and financially advantageous.
기간: 2 years
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2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Talat A Ikizler, MD, Vanderbilt University Medical Center
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. .
angioplasty에 대한 임상 시험
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Jena University HospitalKKS Netzwerk; iVascular S.L.U.완전한