Hepatopulmonary SyndromeHPSNCT03092401
Hepatopulmonary Syndrome and Postoperative Complications After Liver Transplantation : A Case-control Study
An observational study of Hepatopulmonary Syndrome and Liver Cirrhosis, run by Hospices Civils de Lyon.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatopulmonary Syndrome, Liver Cirrhosis
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 31 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent liver transplantation between 2010 and 2016
Who may be able to join
- Liver transplanted patients
Who cannot join
- Living donor transplantation
- Bipartition transplantation
- Non-heat-beating donor transplantation
- Minor
- Double or multiple organ transplantation
- Non cirrhotic patients
- Retransplantation
About this study
Official title: 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.
- Conditions
- Hepatopulmonary Syndrome, Liver Cirrhosis
- Keywords
- Liver transplantation, Hepatopulmonary Syndrome, Liver Cirrhosis
- Medical subject headings
- Hepatopulmonary Syndrome, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hepatic transplant patients with hepatopulmonary syndrome | Not described | |
| hepatic transplant patients without hepatopulmonary syndrome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year post liver transplantation
Secondary outcomes (4)
Length of Mechanical Ventilation
Measured: 1 year post liver transplantation
Length of ICU stay
Measured: 1 year post liver transplantation
Length of Hospital Stay
Measured: 1 year post liver transplantation
Delay of hepatopulmonary syndrome resolution
Measured: 1 year post liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start1 Oct 2015
- Primary completion31 Mar 2017 (estimated)
- Study completion31 Mar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatopulmonary SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092401
- Sponsor's protocol ID
- 69HCL17_0210
- Acronym
- HPS
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2017
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatopulmonary Syndrome and Postoperative Complications After Liver Transplantation : A Case-control Study.
- ClinicalTrials.gov ID
- NCT03092401
- Acronym / sponsor ID
- HPS / 69HCL17_0210
- Conditions
- Hepatopulmonary Syndrome, Liver Cirrhosis
- Keywords
- Liver transplantation, Hepatopulmonary Syndrome, Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Mar 2017 (estimated)
- Study completion
- 31 Mar 2017 (estimated)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hepatic transplant patients with hepatopulmonary syndrome | – | – |
| hepatic transplant patients without hepatopulmonary syndrome | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent liver transplantation between 2010 and 2016
Key inclusion criteria (1 listed)
- Liver transplanted patients
Key exclusion criteria (7 listed)
- Living donor transplantation
- Bipartition transplantation
- Non-heat-beating donor transplantation
- Minor
- Double or multiple organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative complication rates in hepatic transplant patients with or without hepatopulmonary syndrome
Time frame: 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
4 secondary outcomes
Length of Mechanical Ventilation
Time frame: 1 year post liver transplantation
Length of ICU stay
Time frame: 1 year post liver transplantation
Length of Hospital Stay
Time frame: 1 year post liver transplantation
Delay of hepatopulmonary syndrome resolution
Time frame: 1 year post liver transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
Related trials for Hepatopulmonary Syndrome
Enrolling by invitationObservational study
International Registry of Congenital Portosystemic Shunt (IRCPSS)
Congenital Portosystemic Shunt, CPSS (Congenital Portosystemic Shunt)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatopulmonary Syndrome and Liver Cirrhosis, run by Hospices Civils de Lyon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complication rates in hepatic transplant patients with or without hepatopulmonary syndrome (time frame: 1 year post liver transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.