The Compliance and Prognosis of NSBB Secondary Prevention of Cirrhosis With Gastroesophageal Varices Bleeding

NCT ID: NCT03683121

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2021-12-31

Brief Summary

Non-selective beta blockers are commonly used drugs for primary prevention and secondary prevention in patients with cirrhotic decompensated esophageal varices bleeding，the basic heart rate, blood pressure and condition of different patients have individual differences.This paper mainly discusses the compliance of patients taking NSBB under different follow-up methods and analyze the factors affecting patient compliance.

Detailed Description

Esophagogastric variceal hemorrhage is a common complication of decompensated liver cirrhosis and the rate of rebleeding after hemostasis is high.Effective secondary prevention reduces the risk of rebleeding.Non-selective beta blockers are commonly used drugs for secondary prevention.Clinically, there is a great difference in the compliance of patients taking non-selective beta receptor blockers.In this study, the enrolled patients were divided into three groups: the traditional follow-up group (face-to-face interview);Non-traditional follow-up (WeChat, telephone, etc.);Traditional and non-traditional methods of follow-up were combined in the group.The investigators collected the basic data before the patients were enrolled, adjusted the medication dosage according to the patients' condition during the follow-up period, and recorded the treatment during the follow-up period, and analyzed the factors influencing the patients' compliance.

Conditions

Esophageal Varices Bleeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

the traditional follow-up group

The dose and notes for the use of the Non-selective beta blockers were informed during outpatient follow-ups for the patients with a history of esophageal variceal bleeding

No interventions assigned to this group

Non-traditional follow-up

The dose and notes for the use of the Non-selective beta blockers were informed during telephone or WeChat follow-ups for the patients with a history of esophageal variceal bleeding

No interventions assigned to this group

Combine of Group1 and Group2

The dose and notes for the use of the Non-selective beta blockers were informed during outpatient follow-ups for the patients with a history of esophageal variceal bleeding,and the patients were followed up by telephone or WeChat again on the same day.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent

2. All cases met the diagnostic criteria for cirrhosis

3. All patients were confirmed to be combined with esophageal and gastric varices through endoscopy or portal vein CTA or abdominal CT, and had at least one history of esophageal and gastric varices rupture and bleeding. Child-pugh was graded as A/B.

4. All patients had basal heart rate greater than 60 beats/min and systolic pressure greater than 90mmhg.

Exclusion Criteria

1. Patients with liver cancer or other gastrointestinal tumors

2. Patients with splenomegaly due to extrahepatic portal hypertension and noncirrhosis

3. Patients with basal heart rate less than 55 beats/min or systolic pressure less than 90mmhg

4. There are patients with NSBB contraindications such as severe cardiac insufficiency, cardiogenic shock, sinus bradycardia and morbid sinus syndrome, severe ventricular conduction block, bronchial asthma, etc.

5. Patients with other diseases other than liver cirrhosis should take beta blockers (such as coronary heart disease, arrhythmia, etc.).

6. Patient data is incomplete, data cannot be collected and counted

7. Patients who do not agree with secondary prevention after informing them about the adverse reactions associated with medication

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

ChenMingkai

Chief physician of Department of Gastroenterology I

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Mingkai Chen, doctor

Role: primary

kaimingchen@163.com

13720330580

Other Identifiers

ChenMingkai

Identifier Type: -

Identifier Source: org_study_id