ClinicalTrials.gg
Status unknownNCT03435406Updated Feb 19, 2018

Investigation of the Prevalence of Hepatopulmonary Syndrome in Cirrhosis Patients Caused by Hepatitis B in Western China

An observational study in Hepatopulmonary Syndrome, sponsored by Southwest Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by Southwest Hospital, China · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study summary

to investigate the prevalence of hepatopulmonary syndrome in cirrhosis patients caused by Hepatitis B in western China

Read the detailed description

Hepatopulmonary syndrome (HPS) occurs in approximately 4%-29% of cirrhotic patients and influences mortality. China has 100 million Hepatitis B virus (HBV) carriers and Chronic HBV infection is well-recognized risk factor for cirrhosis.But little is known about the prevalence of HPS in cirrhosis patients caused by HBV in western China. The aim of this study was to investigate the HPS incidence, and the signs, symptoms, arterial blood gas, and BMP9 in the serum of the patients.

02

Conditions studied

  • Hepatopulmonary Syndrome

Keywords

  • Hepatitis B, Chronic
  • Cirrhosis
  • Hepatopulmonary Syndrome
03

In context

Hepatitis B, Chronic

895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.

This study's planned enrollment of 300 is below the median of 400 across 206 observational studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

Southwest Hospital, China is the lead sponsor of 87 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients were selected with cirrhosis caused by HBV including Southwest Hospital, the first affiliated hospital of Chongqing Medical University, the People's hospital of Rongchang district and Qijiang District people's hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: 18-80 years old;
  2. American association of anesthesiologists(ASA) score: I-III;
  3. Ability to comply with research programmes;
  4. Voluntary participation in the study;
  5. Has the history of infection;
  6. No primary cardiopulmonary disease (heart disease, emphysema, pneumonia, asthma, etc.)

Exclusion criteria

Exclusion Criteria:

  1. Severe heart, lung, kidney disease coexisted;
  2. American association of anesthesiologists(ASA) score≥IV; forced expiratory volume at one second () or forced vital capacity (FVC) \<70%, or FEV1 / FVC \<0.70;
  3. Mental state could not cooperate
  4. Absence of written .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • cirrhosis with HPS

    Diagnosed as HPS

  • cirrhosis without HPS

    Not Diagnosed as HPS

06

What researchers measure

Primary outcomes

  1. transthoracic contrast enhanced echocardiography (CEE)

    through the ultrasound to evaluate the imagine of cardiac cavity after intravenous injection of agitated saline

    Time frame: During the operation

  2. arterial blood gas

    arterial blood gas analysis was performed through the radial artery.

    Time frame: During the operation

  3. medical history

    The medical history was collected through consultation.

    Time frame: During the operation

  4. acropachy

    acropachy was examined by inspection

    Time frame: During the operation

  5. spider angioma

    spider angioma was examined by inspection

    Time frame: During the operation

  6. liver palms

    liver palms was examined by inspection

    Time frame: During the operation

  7. oxygen saturation

    oxygen saturation was examined by pulse oximetry

    Time frame: During the operation

Secondary outcomes

  1. the content of bone morphogenetic protein (BMP9) in the patients with and without HPS

    the content and expression of BMP9 were determined by immunohistochemistry.

    Time frame: 4 to 6 months after the study completion

  2. micro ribonucleic acid 144 (miR144), micro ribonucleic acid 200 (miR200) in the patients with and without HPS

    the content and expression of BMP9 were determined by polymerase chain reaction (PCR)

    Time frame: 4 to 6 months after the study completion

07

Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology, Southwest Hospital Third Military Medical University
    Chongqing, Chongqing 400038, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03435406
Lead sponsor
Southwest Hospital, China
Responsible party
Lu KZ (Professor of Institute of Anesthesiology, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China, Southwest Hospital, China) — Principal investigator
First posted
Feb 19, 2018
Start date
Jul 27, 2017
Primary completion
Apr 1, 2018 (estimated)
Completion
Apr 1, 2018 (estimated)
Last update
Feb 19, 2018

Study contacts

Yi Bin, PhD
Contact
tang123a123123@163.com
0086-02368754197
tang xi, md
Contact
12923699@qq.com
0086-18623198332
Lu K Zhi, PhD
study director · Department of Anesthesiology, Southwest Hospital Third Military Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion