Impact of Culture of Perfusion Fluid on Donor-derived Infection Management and Outcome in Liver and Kidney Transplant (PREVENT)
This study aims to evaluate whether microbiological testing of the perfusion fluid used to transport transplanted organs can help predict the development of infections in liver and kidney transplant recipients, including possible donor-derived infections (infections transmitted from the donor organ).
The study will include all liver and kidney transplant recipients with available perfusion fluid culture results from 2021 until the start of the study (retrospective phase) and for two years after study initiation (prospective phase).
The study will assess how often high-risk microorganisms are identified in perfusion fluid, whether these findings are associated with complications or infections in recipients, and whether they affect patient outcomes, including mortality.
연구 개요
상세 설명
This study aims to analyze the clinical impact of culture results from the perfusion fluid used for the transport of transplanted organs on the development of infections in recipients, through the assessment of possible donor-derived infections. All patients who undergo liver or kidney transplantation and for whom perfusion fluid culture results are available will be enrolled, from 2021 until the start of the study (retrospective phase) and for a period of two years after study initiation (prospective phase).
The hypothesis underlying the study is that analysis of the organ perfusion fluid may, to some extent, predict the development of infections in patients undergoing liver or kidney transplantation. The study will also evaluate the frequency of perfusion fluids in which pathogens associated with a high risk of infection in the recipient are isolated; the frequency of complications in recipients; and mortality among recipients of organs with perfusion fluids containing high-risk pathogens compared with those containing low-risk pathogens or negative cultures.
During the prospective phase, strains isolated from the perfusion fluid and from recipient samples will be stored. Whenever a donor-derived infection is suspected (e.g., the same pathogen isolated from the perfusion fluid and subsequently from the recipient), strains isolated from the donor and recipient will undergo sequencing to confirm the clinical suspicion.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Maddalena Giannella, MD, PhD
- 전화번호: +39 051 2143199
- 이메일: maddalena.giannella@unibo.it
연구 연락처 백업
- 이름: Matteo Rinaldi, MD
- 전화번호: +39 051 2143595
- 이메일: matteo.rinaldi@aosp.bo.it
연구 장소
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Italy
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Bologna, Italy, 이탈리아, 40128
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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연락하다:
- Matteo Rinaldi, MD
- 전화번호: +39 051 2143595
- 이메일: matteo.rinaldi@aosp.bo.it
-
수석 연구원:
- Matteo Rinaldi, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods
- Availability of graft preservation fluid culture results
- Signed informed consent
Exclusion Criteria:
- None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO
Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To evaluate the clinical impact of high-risk perfusion fluid cultures in terms of infectious complications
기간: At 30, 90, and 180 days post-transplant
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To evaluate the clinical impact of high-risk perfusion fluid cultures in both liver and kidney transplant recipients.
This impact is defined as the frequency of bacterial/fungal donor-derived infections (confirmed by matching the specific strain isolated from the preservation fluid with the strain isolated from the recipient) and overall bacterial/fungal infections at 30, 90, and 180 days post-transplant, comparing patients with high-risk perfusion fluid cultures against those with low-risk or negative cultures
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At 30, 90, and 180 days post-transplant
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To describe the management of positive fluid cultures
기간: During the post-transplant follow-up period (up to 180 days)
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To describe the clinical management of positive perfusion fluid culture results, specifically detailing the targeted antibiotic treatment (when administered), its duration, and the instrumental monitoring performed during follow-up
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During the post-transplant follow-up period (up to 180 days)
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To assess graft function
기간: At 180 days post-transplantation
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To assess graft function at 180 days post-transplant across the study groups
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At 180 days post-transplantation
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To assess patient survival
기간: At 180 days post-transplantation
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To assess all-cause mortality at 180 days post-transplant across the study groups
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At 180 days post-transplantation
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To confirm donor-derived infections at a molecular level (prospective phase only)
기간: During the data analysis phase (Months 31-33)
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To store microorganisms isolated from preservation/perfusion fluid and recipient samples (collected as part of routine clinical practice) and to perform Whole Genome Sequencing on strains isolated from donor and recipient in cases of suspected donor-derived infection to confirm or rule out donor-derived pathogen transmission (prospective phase only)
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During the data analysis phase (Months 31-33)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Matteo Rinaldi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PREVENT (Janssen Biotech Inc.)
- RC-2026-2802100 (기타 보조금/기금 번호: Italian Ministry of Health)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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