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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Maddalena Giannella, MD, PhD
- Numero di telefono: +39 051 2143199
- Email: maddalena.giannella@unibo.it
Backup dei contatti dello studio
- Nome: Matteo Rinaldi, MD
- Numero di telefono: +39 051 2143595
- Email: matteo.rinaldi@aosp.bo.it
Luoghi di studio
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Italy
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Bologna, Italy, Italia, 40128
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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Contatto:
- Matteo Rinaldi, MD
- Numero di telefono: +39 051 2143595
- Email: matteo.rinaldi@aosp.bo.it
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Investigatore principale:
- Matteo Rinaldi, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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To evaluate the clinical impact of high-risk perfusion fluid cultures in terms of infectious complications
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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To describe the management of positive fluid cultures
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Matteo Rinaldi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PREVENT (Janssen Biotech Inc.)
- RC-2026-2802100 (Altro numero di sovvenzione/finanziamento: Italian Ministry of Health)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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