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

NCT ID: NCT02119585

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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End Stage Liver Diseases

Keywords

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orthotopic liver transplantation ischemia reperfusion syndrome cytokines respiratory system elastance lung elastance chest wall elastance shunt dead space acute respiratory failure atelectasis pleural effusion

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing OLT

insertion of nasogastric tube for measurements of chest wall mechanics

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* orthotopic liver transplantation
* valid informed consent

Exclusion Criteria

* Age \< 18 yrs
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Vito Fanelli MD, PhD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, Turin, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Vito Fanelli, MD, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Vito Fanelli, MD, PhD

Role: primary

Other Identifiers

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0077687

Identifier Type: -

Identifier Source: org_study_id