Hepatopulmonary Syndrome and Postoperative Complications After Liver Transplantation : A Case-control Study (HPS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis; Hepatopulmonary Syndrome

• Study Type: Observational
• Enrollment (Actual): 142

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who underwent liver transplantation between 2010 and 2016

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
hepatic transplant patients with hepatopulmonary syndrome
hepatic transplant patients without hepatopulmonary syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Time Frame
Length of Mechanical Ventilation	1 year post liver transplantation
Length of ICU stay	1 year post liver transplantation
Length of Hospital Stay	1 year post liver transplantation
Delay of hepatopulmonary syndrome resolution	1 year post liver transplantation

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Anticipated): March 31, 2017
• Study Completion (Anticipated): March 31, 2017

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Liver transplantation; Liver Cirrhosis; Hepatopulmonary Syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease; Liver Diseases; Fibrosis; Syndrome; Liver Cirrhosis; Postoperative Complications; Hepatopulmonary Syndrome
• Other Study ID Numbers: 69HCL17_0210

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No