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

• Conditions: Liver Cirrhosis; Hepatopulmonary Syndrome

• Registration Number: NCT03092401
• Lead Sponsor: Hospices Civils de Lyon

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 available

Study Timeline

• Study Start: 2015-10-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-27
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• Liver transplanted patients

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Length of Mechanical Ventilation	1 year post liver transplantation
Length of ICU stay	1 year post liver transplantation
Delay of hepatopulmonary syndrome resolution	1 year post liver transplantation
Length of Hospital Stay	1 year post liver transplantation