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

NCT03683121 | Unknown

• 1 other identifier: ChenMingkai
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Varices Bleeding

Keywords

Esophagogastric variceal hemorrhage; cirrhosis; secondary prevention; Non-selective beta blocker; compliance

Outcome Measures

Primary Outcomes (1)

• Heart rate compliance ratio after treatment with NSBBs

  In this single-center study, 83 patients were included, including 9 cases lost to follow-up, 1 case died, and 1 case was excluded from liver cancer. a total of 72 cases were included, with an average follow-up time of 185.3 days.Among the 72 patients who were not lost to follow-up, 40 NSBBs patients had good medication compliance, and 34 patients achieved heart rate response (34/40,85.0%).

  10 months

Secondary Outcomes (2)

• Different follow-up methods were used to guide non-hospitalized patients to take medication in NSBBs, and the compliance of patients with NSBBs and its influencing factors were analyzed

  10 months

• The compliance of gastroscopy and bleeding of esophageal and gastric varices during the follow-up period were analyzed

  10 months

Study Arms (3)

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

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

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patient was diagnosed with liver cirrhosis in the investigator's hospital or the outer court and had a history of esophageal variceal rupture and bleeding before into the group

You may qualify if:

• Signed informed consent
• All cases met the diagnostic criteria for cirrhosis
• 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.
• All patients had basal heart rate greater than 60 beats/min and systolic pressure greater than 90mmhg.

You may not qualify if:

• Patients with liver cancer or other gastrointestinal tumors
• Patients with splenomegaly due to extrahepatic portal hypertension and noncirrhosis
• Patients with basal heart rate less than 55 beats/min or systolic pressure less than 90mmhg
• 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.
• Patients with other diseases other than liver cirrhosis should take beta blockers (such as coronary heart disease, arrhythmia, etc.).
• Patient data is incomplete, data cannot be collected and counted
• Patients who do not agree with secondary prevention after informing them about the adverse reactions associated with medication

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

MeSH Terms

Conditions

Fibrosis; Patient Compliance

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of Department of Gastroenterology I

Study Record Dates

• First Submitted: September 15, 2018
• First Posted: September 25, 2018
• Study Start: July 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

CN (1)