Analysis of Respiratory System Mechanics and Inflammatory Response During Orthotopic Liver Transplantation (SPPLIT Trial) (SPPLIT)

December 15, 2014 updated by: Vito Fanelli MD, PhD, University of Turin, Italy

Observational Study to Analyze Respiratory System Mechanics Changes and Inflammatory Responses During Orthotopic Liver Transplantation (SPPLIT Trial)

During orthotopic liver transplantation (OLT), respiratory system function may be severely impaired for several reasons including anaesthesia effects, hyperdynamic volume state with fluid overload and ischemia reperfusion injury. In particular, reperfusion syndrome is characterised by the release of several inflammatory mediators such as cytokines and oxygen free radicals which may contribute to alveolar endothelial barrier dysfunction. The object of this study is to investigate the respiratory system mechanics impairment in its partitioning between lung and chest wall.

We hypothesize that impairment of respiratory system mechanics (of both lung and chest wall) occurs after reperfusion phase of liver. This impairment is associated with the systemic inflammatory response following liver reperfusion.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10126
        • Recruiting
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with end stage liver diseases undergoing to liver transplantation

Description

Inclusion Criteria:

  • orthotopic liver transplantation
  • valid informed consent

Exclusion Criteria:

  • Age < 18 yrs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients undergoing OLT
insertion of nasogastric tube for measurements of chest wall mechanics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Elastance of Respiratory System, Lung and Chest Wall
Time Frame: at 90 minutes after liver reperfusion
at 90 minutes after liver reperfusion
Elastance of Respiratory System, Lung and Chest Wall
Time Frame: at 3 hours after liver reperfusion
at 3 hours after liver reperfusion
Elastance of Respiratory System, Lung and Chest Wall
Time Frame: at 24 hours after liver reperfusion
at 24 hours after liver reperfusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Ventilator free days
Time Frame: 28 days
28 days
ICU length of stay
Time Frame: 28 days
28 days
hospital length of stay
Time Frame: 28 days
28 days
Acute respiratory failure
Time Frame: 28 days
28 days
Inflammatory mediators in plasma samples
Time Frame: baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase
baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase
Inflammatory mediators in urine samples
Time Frame: baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase
baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

April 14, 2014

First Submitted That Met QC Criteria

April 18, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 15, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0077687

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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