NCT03092401

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

March 20, 2017

Last Update Submit

March 27, 2017

Conditions

Keywords

Liver transplantationHepatopulmonary SyndromeLiver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • 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 (4)

  • 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

Study Arms (2)

hepatic transplant patients with hepatopulmonary syndrome

hepatic transplant patients without hepatopulmonary syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent liver transplantation between 2010 and 2016

You may qualify if:

  • Liver transplanted patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatopulmonary SyndromeLiver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 27, 2017

Study Start

October 1, 2015

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

March 28, 2017

Record last verified: 2017-03