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

• Conditions: Esophageal Varices Bleeding

• Registration Number: NCT03683121
• Lead Sponsor: Renmin Hospital of Wuhan University

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.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-09-15
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-23
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate compliance ratio after treatment with NSBBs	10 months	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%).

Secondary Outcome Measures

Name	Time	Method
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	Three follow-up methods guided secondary prevention of NSBBs, and the compliance of patients in the remote platform follow-up group and the outpatient clinic combined with the remote platform follow-up group was higher than that in the outpatient follow-up group (P \< 0.05).There was no statistically significant difference in patient compliance between the remote platform follow-up group and the outpatient combined remote platform follow-up group.In outpatient follow-up, there was a statistically significant difference between the subgroup of NSBBs with good compliance and poor compliance, and the local resident patients had better compliance
The compliance of gastroscopy and bleeding of esophageal and gastric varices during the follow-up period were analyzed	10 months	The compliance of the subgroup of NSBBs with good medication compliance was 30/40 (75.0%) during the follow-up period of gastroscopy, and 14/30 (46.7%) after gastroscopy was followed up for sequential endoscopic treatment.Poor compliance of NSBBs subgroup during the follow-up period, the compliance of gastroscopy was 7/32 (21.9%), and 3/7 (42.9%) after gastroscopy, sequential treatment under endoscopy.During the follow-up period, the subgroup with good medication compliance of NSBBs had higher compliance with gastroscopy than the subgroup with poor medication compliance (P=0.000).

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China