Clinical trial NCT03683121: The Compliance and Prognosis of NSBB Secondary Prevention of Cirrhosis With Gastroesophageal Varices Bleeding
Official title: Effect of Different Follow-up Methods on Compliance and Prognosis of NSBB Secondary Prevention of Cirrhosis With Gastroesophageal Varices Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Varices Bleeding
Keywords: Esophagogastric variceal hemorrhage
cirrhosis
secondary prevention
Non-selective beta blocker
compliance
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Heart rate compliance ratio after treatment with NSBBs
timeFrame: 10 months
Secondary outcomes:
measure: 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
timeFrame: 10 months
measure: The compliance of gastroscopy and bleeding of esophageal and gastric varices during the follow-up period were analyzed
timeFrame: 10 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References: