Clinical trial NCT03435406: Investigation of the Prevalence of Hepatopulmonary Syndrome in Cirrhosis Patients Caused by Hepatitis B in Western China
Official title: Investigation of the Prevalence of Hepatopulmonary Syndrome in Cirrhosis Patients Caused by Hepatitis B in Western China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatopulmonary Syndrome
Keywords: Hepatitis B, Chronic
Cirrhosis
Hepatopulmonary Syndrome
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: transthoracic contrast enhanced echocardiography (CEE)
timeFrame: During the operation
measure: arterial blood gas
timeFrame: During the operation
measure: medical history
timeFrame: During the operation
measure: acropachy
timeFrame: During the operation
measure: spider angioma
timeFrame: During the operation
measure: liver palms
timeFrame: During the operation
measure: oxygen saturation
timeFrame: During the operation
Secondary outcomes:
measure: the content of bone morphogenetic protein (BMP9) in the patients with and without HPS
timeFrame: 4 to 6 months after the study completion
measure: micro ribonucleic acid 144 (miR144), micro ribonucleic acid 200 (miR200) in the patients with and without HPS
timeFrame: 4 to 6 months after the study completion
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Anesthesiology, Southwest Hospital Third Military Medical University
state: Chongqing
Study officials:
affiliation: Department of Anesthesiology, Southwest Hospital Third Military Medical University
name: Lu K Zhi, PhD
role: STUDY_DIRECTOR
References: