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

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ClinicalTrials.gov Identifier: NCT03683121
Recruitment Status : Not yet recruiting
First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
ChenMingkai, 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.

Condition or disease
Esophageal Varices Bleeding

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
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Different Follow-up Methods on Compliance and Prognosis of NSBB Secondary Prevention of Cirrhosis With Gastroesophageal Varices Bleeding
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 1, 2019


Group/Cohort
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.



Primary Outcome Measures :
  1. Heart rate compliance ratio after treatment with NSBBs [ Time Frame: 6 months ]
    In this study, the heart rate of NSBBs was up to 55-60 beats/min or 20% lower than the baseline value.The number of people who achieved heart rate in this group/(the number of participants in this group - the number of excluded in this group) was used for NSBBs medication compliance evaluation


Secondary Outcome Measures :
  1. time to recurrence [ Time Frame: 6 months ]
    Recurrent esophagogastric variceal hemorrhage (including acute esophagogastric variceal hemorrhage and gastroscopic red positive) during follow-up

  2. Child-pugh grading evaluation [ Time Frame: 6 months ]
    Child-pugh classification and score were evaluated at the end of the follow-up.Child-pugh scores were composed of hepatic encephalopathy (stage), ascites, total bilirubin (umol/L), albumin (g/L), and prothrombin time (>Contrast seconds).

  3. mortality rate [ Time Frame: 6 months ]
    The number and proportion of deaths from cirrhosis-related complications were counted at the end of the follow-up



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683121


Locations
China, Hubei
Renmin Hospital of Wuhan University Not yet recruiting
Wuhan, Hubei, China, 430060
Sponsors and Collaborators
Renmin Hospital of Wuhan University

Responsible Party: ChenMingkai, Chief physician of Department of Gastroenterology I, Renmin Hospital of Wuhan University
ClinicalTrials.gov Identifier: NCT03683121     History of Changes
Other Study ID Numbers: ChenMingkai
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ChenMingkai, Renmin Hospital of Wuhan University:
Esophagogastric variceal hemorrhage
cirrhosis
secondary prevention
Non-selective beta blocker
compliance

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Fibrosis
Liver Cirrhosis
Varicose Veins
Esophageal and Gastric Varices
Pathologic Processes
Liver Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs