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NCT03363646 Clinical Trial

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

Sepsis Clinical Trial

— INFE-OLT  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03363646
Other study ID # CEAVNO 56304
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date August 30, 2019

Study information
Verified date September 2018
Source Azienda Ospedaliero, Universitaria Pisana
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date August 30, 2019
Est. primary completion date August 20, 2019
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy U.O. Anestesia e Rianimazione Trapianti Pisa

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical number and severity of infectious episodes 18 months
Primary microbiological describe the type of infectious agents 18 months
Secondary Resistance antibiotic resistance patters of the isolates 18 months
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