- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03683121
The Compliance and Prognosis of NSBB Secondary Prevention of Cirrhosis With Gastroesophageal Varices Bleeding
March 19, 2021 updated by: ChenMingkai, Renmin Hospital of Wuhan University
Effect of Different Follow-up Methods on Compliance and Prognosis of NSBB Secondary Prevention of Cirrhosis With Gastroesophageal Varices Bleeding
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
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Wuhan, Hubei, China, 430060
- Recruiting
- Renmin Hospital of Wuhan University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%).
|
10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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
|
10 months
|
The compliance of gastroscopy and bleeding of esophageal and gastric varices during the follow-up period were analyzed
Time Frame: 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).
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10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2018
Primary Completion (ANTICIPATED)
December 31, 2021
Study Completion (ANTICIPATED)
December 31, 2021
Study Registration Dates
First Submitted
September 15, 2018
First Submitted That Met QC Criteria
September 21, 2018
First Posted (ACTUAL)
September 25, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 23, 2021
Last Update Submitted That Met QC Criteria
March 19, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChenMingkai
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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