Italian National Study on the Critically Ill Liver Transplant Patient With an Infection

NCT ID: NCT03363646

Last Updated: 2018-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-08-30

Brief Summary

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Despite major advances, infections remain one of the major causes of morbidity and mortality in patients undergoing orthotopic liver transplantation (OLT). Furthermore, data on the epidemiology, severity, and type of post-OLT infections nowadays available come from dated, monocentric, retrospective series. Finally, there is no available data focused on the critical OLT patient admitted to the Intensive Care Unit (ICU). Therefore this study was conceived (1) to describe incidence, severity, epidemiology and outcomes of infections recorded in OLT patients in the ICU (first or re-admission ); (2) to identify possible risk factors and (3) to report the type of the involved microorganism with their antibiotic sensitivity pattern

Detailed Description

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The study will record clinical, epidemiological and microbiological data from the clinical files of OLT patients admitted at italian ICUs

Conditions

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Liver Transplantation Infection Sepsis Intensive Care Unit

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age\> 18 aa
2. Sex: Both
3. written consent to participate in the study
4. having been undergone to OLT in the 10 years prior to enrollment
5. Infection diagnosis (any type, any localization, any agent)
6. Being admitted in the ICU

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role lead

Responsible Party

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Gianni Biancofiore

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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U.O. Anestesia e Rianimazione Trapianti

Pisa, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Gianni Biancofiore

Role: primary

+39050995409

Other Identifiers

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CEAVNO 56304

Identifier Type: -

Identifier Source: org_study_id

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