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

Hepatopulmonary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03435406
• Other study ID #: CEE-HBV
• Status: Recruiting
• Phase: N/A
• First received: February 2, 2018
• Last updated: February 9, 2018
• Start date: July 27, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: February 2018
• Source: Southwest Hospital, China
• Contact: Yi Bin, PhD
• Phone: 0086-02368754197
• Email: tang123a123123[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 HBV infection;

6. No primary cardiopulmonary disease (heart disease, emphysema, pneumonia, asthma, etc.)

Exclusion Criteria:

1. Severe heart, lung, kidney disease coexisted;

2. American association of anesthesiologists(ASA) score=IV; forced expiratory volume at one second (FEV1) or forced vital capacity (FVC) <70%, or FEV1 / FVC <0.70;

3. Mental state could not cooperate

4. Absence of written informed consent.

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis B
• Hepatopulmonary Syndrome
• Liver Cirrhosis
• Syndrome

Locations

Country	Name	City	State
China	Department of Anesthesiology, Southwest Hospital Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transthoracic contrast enhanced echocardiography (CEE)	through the ultrasound to evaluate the imagine of cardiac cavity after intravenous injection of agitated saline	During the operation
Primary	arterial blood gas	arterial blood gas analysis was performed through the radial artery.	During the operation
Primary	medical history	The medical history was collected through consultation.	During the operation
Primary	acropachy	acropachy was examined by inspection	During the operation
Primary	spider angioma	spider angioma was examined by inspection	During the operation
Primary	liver palms	liver palms was examined by inspection	During the operation
Primary	oxygen saturation	oxygen saturation was examined by pulse oximetry	During the operation
Secondary	the content of bone morphogenetic protein (BMP9) in the patients with and without HPS	the content and expression of BMP9 were determined by immunohistochemistry.	4 to 6 months after the study completion
Secondary	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)	4 to 6 months after the study completion