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Clinical Trials/NCT03683121
NCT03683121
Unknown
Not Applicable

Effect of Different Follow-up Methods on Compliance and Prognosis of NSBB Secondary Prevention of Cirrhosis With Gastroesophageal Varices Bleeding

Renmin Hospital of Wuhan University1 site in 1 country90 target enrollmentJuly 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Varices Bleeding
Sponsor
Renmin Hospital of Wuhan University
Enrollment
90
Locations
1
Primary Endpoint
Heart rate compliance ratio after treatment with NSBBs
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ChenMingkai

Chief physician of Department of Gastroenterology I

Renmin Hospital of Wuhan University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Heart rate compliance ratio after treatment with NSBBs

Time Frame: 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 Outcomes

  • 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 Sites (1)

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