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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363646
Recruitment Status : Unknown
Verified September 2018 by Gianni Biancofiore, University of Pisa.
Recruitment status was:  Recruiting
First Posted : December 6, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Gianni Biancofiore, University of Pisa

Brief 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

Condition or disease
Liver Transplantation Infection Sepsis 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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Italian National Multicenter Study on Infections in the Critically Ill Liver Transplant Recipient
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : August 20, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Clinical [ Time Frame: 18 months ]
    number and severity of infectious episodes

  2. microbiological [ Time Frame: 18 months ]
    describe the type of infectious agents


Secondary Outcome Measures :
  1. Resistance [ Time Frame: 18 months ]
    antibiotic resistance patters of the isolates



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
liver transplant recipients
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363646


Locations
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Italy
U.O. Anestesia e Rianimazione Trapianti Recruiting
Pisa, Italy, 56100
Contact: Gianni Biancofiore    +39050995409    g.biancofiore@med.unipi.it   
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
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Responsible Party: Gianni Biancofiore, Associate Professor, University of Pisa
ClinicalTrials.gov Identifier: NCT03363646    
Other Study ID Numbers: CEAVNO 56304
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases