Italian National Study on the Critically Ill Liver Transplant Patient With an Infection (INFE-OLT)

Italian National Multicenter Study on Infections in the Critically Ill Liver Transplant Recipient

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

Study Overview

• Status: Unknown
• Conditions: Liver Transplantation; Sepsis; Infection; Intensive Care Unit

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56100
    • Recruiting
    • U.O. Anestesia e Rianimazione Trapianti
    • Contact: Gianni Biancofiore; Phone Number: +39050995409; Email: g.biancofiore@med.unipi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

liver transplant recipients

Description

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 1. Death within 72 hours of admission 2. Withdrawal of consent

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical	number and severity of infectious episodes	18 months
microbiological	describe the type of infectious agents	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resistance	antibiotic resistance patters of the isolates	18 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero, Universitaria Pisana

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): August 20, 2019
• Study Completion (Anticipated): August 30, 2019

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: CEAVNO 56304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No