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Analysis of CRBSI Rates in Patients With a NexSite™ HD (Hemodialysis) Catheter

2018년 9월 28일 업데이트: Marvao Medical

Analysis of CRBSI (Catheter-Related Blood Stream Infection) Rates in Patients With a NexSite™ HD (Hemodialysis) Catheter

A U.S. multi-centre post approval registry to analyse the CRBSI rate in patients with the NexSite HD Catheter for long term vascular access for hemodialysis.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This is a U.S. multi - centre, prospective, non-randomized post approval registry. Approximately one hundred and twenty patients will be implanted with a NexSite HD catheter at four to eight U.S. sites where hemodialysis catheters are routinely implanted. Each site may enrol a maximum of 50 patients. Enrolled patients will be followed from device placement to device removal or 180 days post device placement. Patients will be enrolled once only.

The primary endpoint is CRBSI rate related to the NexSite HD catheter. Determination of infection will be decided by the investigator and if necessary adjudicated by the CEC (Clinical Events Committee) based on blood culture results, regardless of whether the catheter is removed.

Secondary endpoints for the study are

  • Successful placement and continued use of the NexSite HD device designed for use in patients requiring long term hemodialysis.
  • Healing of catheter exit site
  • Tunnel Infections
  • Exit site infections
  • Early non-infectious complications associated with CVCs
  • Late non-infectious complications associated with Central Venous Catheters

연구 유형

중재적

등록 (실제)

120

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • North Carolina
      • Greenville, North Carolina, 미국, 27834
        • Eastern Nephrology Associates
      • New Bern, North Carolina, 미국, 28542
        • Eastern Nephology Associates
      • Raleigh, North Carolina, 미국, 27610
        • Capital Nephrology Associates
    • South Carolina
      • Orangeburg, South Carolina, 미국, 29118
        • South Carolina Nephrology and Hypertension Center Inc
    • Texas
      • Lubbock, Texas, 미국, 79416
        • Lubbock Vascular Access Centre
      • San Antonio, Texas, 미국, 78215
        • Renal Associates

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. The patient shall be 18 - 80 years old.
  2. The patient requires the placement of a long term tunnelled HD catheter for administration of hemodialysis.
  3. The patient has anticipated survival in excess of 90 days from the anticipated date of catheter placement.
  4. The patient has the ability to understand the research subject information and sign a written Informed Consent form which must be obtained prior to initiation of the study.
  5. The patient receives the catheter via the internal jugular or subclavian vein.
  6. All female patients of child bearing potential must complete a negative pregnancy test and will confirm that they are not breastfeeding.

Exclusion Criteria:

  1. The patient is participating in another IRB (Institutional Review Board) clinical trial, which modifies standard-of-care treatment and/or involves an investigational device or drug.
  2. The patient has a confirmed or suspected infection, bacteraemia or septicaemia.
  3. The patient's physiology is NOT suitable for placement of the NexSite device; this will include an examination of the anatomy at the proposed catheter exit site.
  4. The patient is known or suspected to have allergies to the materials used in the construction of the device.
  5. The patient has previously suffered from coagulation issues or has had vascular surgery at the proposed placement site.
  6. The patient has received radiation treatment at the proposed catheter placement site.
  7. The patient has severe chronic obstructive lung disease.
  8. The patient is pyretic within 72 hours (temperature ≥38o C or 100.4oF) prior to placement and/or has received antimicrobial drugs within two weeks prior to catheterisation.
  9. The patient is female of child bearing potential not using adequate contraception. (Adequate contraception is defined as abstinence, intrauterine device [IUD], birth control pills, or spermicidal gel with diaphragm or condom)
  10. The patient has another indwelling catheter.
  11. The patient has non-healing diabetic foot ulcers.
  12. The patient did not give informed consent.
  13. The patient would be unavailable for follow-up.
  14. The patient is a permanent nursing home resident.
  15. The proposed access site is not the internal jugular or subclavian vein.
  16. The patient is scheduled to undergo an elective surgical procedure (other than a procedure to create a graft or fistula) within the study timeframe.
  17. Any other condition that the Investigator believes should exclude the patient from the study.
  18. The patient does not have English or Spanish as their first language.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: NexSite HD Patients
NexSite HD patient catheter device placement
장치: NexSite HD Patients
Measurement of CRBSI rate and other device related adverse events in patients with NexSite HD Catheter.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of participants with Catheter-Related Blood Stream Infection (CRBSI)(bacteremia/fungemia) as an adverse event.
기간: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with a confirmed CRBSI for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)

2차 결과 측정

결과 측정
측정값 설명
기간
Number of participants with adverse events associated with device placement and use.
기간: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with adverse events associated with device placement and for the duration of catheter use or to 180 days post device placement.
Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with unhealed catheter exit sites
기간: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with unhealed exit sites for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with tunnel infection as an adverse event
기간: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with a tunnel infection for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with exit site infection as an adverse event
기간: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with a exit site infection for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with Pneumothorax, haemothorax, arrhythmia, air embolism or arterial perforation as an adverse event.
기간: 1 day of device placement
Number of participants with non-infectious catheter complications within one day of placement.
1 day of device placement
Number of participants with Catheter dislodgement, Catheter tip dislodgement and catheter thrombosis as an adverse event.
기간: Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)
Number of participants with late non infectious complications for the duration of catheter use or to 180 days post device placement (whichever occurs first).
Participants will be followed for the duration of catheter use or to 180 days post device placement (whichever occurs first)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Marvao Medical

수사관

  • 수석 연구원: Jeffrey G Hoggard, MD, Capital Nephrology Associates

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2015년 4월 1일

기본 완료 (실제)

2017년 9월 1일

연구 완료 (실제)

2018년 7월 1일

연구 등록 날짜

최초 제출

2015년 5월 18일

QC 기준을 충족하는 최초 제출

2015년 5월 22일

처음 게시됨 (추정)

2015년 5월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 10월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 9월 28일

마지막으로 확인됨

2018년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TR 0147

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다