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

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

Study Overview

• Status: Unknown
• Conditions: Hepatopulmonary Syndrome

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Yi Bin, PhD; Phone Number: 0086-02368754197; Email: tang123a123123@163.com
• Study Contact Backup: Name: tang xi, md; Phone Number: 0086-18623198332; Email: 12923699@qq.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Department of Anesthesiology, Southwest Hospital Third Military Medical University
      • Contact: Yi Bin, PhD; Phone Number: 0086-18502340072; Email: tang123a123123@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
cirrhosis with HPS; Diagnosed as HPS
cirrhosis without HPS; Not Diagnosed as HPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
transthoracic contrast enhanced echocardiography (CEE)	through the ultrasound to evaluate the imagine of cardiac cavity after intravenous injection of agitated saline	During the operation
arterial blood gas	arterial blood gas analysis was performed through the radial artery.	During the operation
medical history	The medical history was collected through consultation.	During the operation
acropachy	acropachy was examined by inspection	During the operation
spider angioma	spider angioma was examined by inspection	During the operation
liver palms	liver palms was examined by inspection	During the operation
oxygen saturation	oxygen saturation was examined by pulse oximetry	During the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Investigators: Study Director: Lu K Zhi, PhD, Department of Anesthesiology, Southwest Hospital Third Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2017
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Cirrhosis; Hepatitis B, Chronic; Hepatopulmonary Syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Lung Diseases; Disease; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Fibrosis; Syndrome; Hepatitis B; Hepatitis; Hepatopulmonary Syndrome
• Other Study ID Numbers: CEE-HBV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No