Analysis of Respiratory System Mechanics and Inflammatory... | NCT02119585

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

NCT02119585

Sponsor

University of Turin, Italy

Status

Unknown status

Last Update Posted

Dec 16, 2014Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

End Stage Liver Diseases

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Jan 2015Estimated

First Submitted Date

Apr 14, 2014

First Submission Date that Met QC Criteria

Apr 18, 2014

First Posted Date

Apr 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2014

Last Update Posted Date

Dec 16, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vito Fanelli MD, PhD, Assistant professor, University of Turin, ItalyPrincipal Investigator

Lead Sponsor

University of Turin, ItalyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing OLT		insertion of nasogastric tube for measurements of chest wall mechanics

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Acute respiratory failure		28 days
Ventilator free days		28 days
ICU length of stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

orthotopic liver transplantation
valid informed consent

Exclusion Criteria:

Age < 18 yrs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

patients with end stage liver diseases undergoing to liver transplantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vito Fanelli, MD, PhD	Contact			vito.fanelli@unito.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliera Città della Salute e della Scienza di Torino	Recruiting	Turin	Turin	10126	Italy

Condition Browse Module

MeSH Terms

ID	Term
D001261	Pulmonary Atelectasis
D010996	Pleural Effusion

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D010995	Pleural Diseases

Browse Leaves

Not provided

Browse Branches

Not provided