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

End Stage Liver Diseases Clinical Trial

— SPPLIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02119585
• Other study ID #: 0077687
• Status: Recruiting
• Phase: N/A
• First received: April 14, 2014
• Last updated: December 15, 2014
• Start date: February 2014
• Est. completion date: January 2015

Study information

• Verified date: December 2014
• Source: University of Turin, Italy
• Contact: Vito Fanelli, MD, PhD
• Email: vito.fanelli[@]unito.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• orthotopic liver transplantation

• valid informed consent

Exclusion Criteria:

• Age < 18 yrs

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• End Stage Liver Disease
• End Stage Liver Diseases
• Liver Diseases

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elastance of Respiratory System, Lung and Chest Wall		at 90 minutes after liver reperfusion	No
Primary	Elastance of Respiratory System, Lung and Chest Wall		at 3 hours after liver reperfusion	No
Primary	Elastance of Respiratory System, Lung and Chest Wall		at 24 hours after liver reperfusion	No
Secondary	Acute respiratory failure		28 days	No
Secondary	Ventilator free days		28 days	No
Secondary	ICU length of stay		28 days	No
Secondary	hospital length of stay		28 days	No
Secondary	Inflammatory mediators in plasma samples		baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase	No
Secondary	Inflammatory mediators in urine samples		baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase	No