Hepatopulmonary Syndrome and Postoperative Complications... | NCT03092401

Studies
Hepatopulmonary Syndrome and Postoperative Complications After Liver Transplantation : A Case-control Study

NCT03092401

Sponsor

Hospices Civils de Lyon

Status

Unknown status

Last Update Posted

Mar 28, 2017Actual

Enrollment

142Actual

Phase

Not provided

Conditions

Hepatopulmonary Syndrome
Liver Cirrhosis

Interventions

Not provided

Countries

Not provided

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

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2015Actual

Primary Completion Date

Mar 31, 2017Estimated

Completion Date

Mar 31, 2017Estimated

First Submitted Date

Mar 20, 2017

First Submission Date that Met QC Criteria

Mar 24, 2017

First Posted Date

Mar 27, 2017Actual

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

Mar 27, 2017

Last Update Posted Date

Mar 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Hepatopulmonary Syndrome is a respiratory complication of liver cirrhosis defined as a triad: hypoxemia (PaO2 < 80 mmHg in room air), chronic liver disease and intrapulmonary vasodilatations. Its prevalence varies between 4 and 32%. Numerous treatments have been tried but the only efficient therapy to cure the syndrome is liver transplantation. Without transplantation it is associated with a higher mortality which is the reason why hepatopulmonary syndrome patients have a higher priority to transplantation. However it appears in some restricted studies that hepatopulmonary syndrome is associated with more postoperative complications (infections, vascular and biliary complications, prolonged length of mechanical ventilation…).

The investigators hypothesised that hepatopulmonary syndrome patients have more postoperative complications after liver transplantation than non hepatopulmonary syndrome patients matched on age, MELD (Model for End-Stage Liver Disease) score, comorbidities, perioperative transfusion and noradrenaline doses.

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

No data available

No data is available for this block.

Enrollment

142Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative complication rates in hepatic transplant patients with or without hepatopulmonary syndrome	Collection of medical (cardiac, pulmonary, renal, infectious, neurological) and Surgical (vascular, digestive) complications in hepatic transplant patients with or without hepatopulmonary syndrome	1 year post liver transplantation

Secondary Outcomes

Measure	Description	Time Frame
Length of Mechanical Ventilation		1 year post liver transplantation
Length of ICU stay		1 year post liver transplantation
Length of Hospital Stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Liver transplanted patients

Exclusion Criteria:

Living donor transplantation
Bipartition transplantation
Non-heat-beating donor transplantation
Minor
Double or multiple organ transplantation
Non cirrhotic patients
Retransplantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent liver transplantation between 2010 and 2016

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D020065	Hepatopulmonary Syndrome
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
hepatic transplant patients with hepatopulmonary syndrome
hepatic transplant patients without hepatopulmonary syndrome