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

Liver Cirrhosis Clinical Trial

— HPS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03092401
• Other study ID #: 69HCL17_0210
• Status: Active, not recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: March 27, 2017
• Start date: October 1, 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: March 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 142
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Hepatopulmonary Syndrome
• Liver Cirrhosis
• Postoperative Complications
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of Mechanical Ventilation		1 year post liver transplantation
Secondary	Length of ICU stay		1 year post liver transplantation
Secondary	Length of Hospital Stay		1 year post liver transplantation
Secondary	Delay of hepatopulmonary syndrome resolution		1 year post liver transplantation