Esophageal Varices BleedingNCT03683121
The Compliance and Prognosis of NSBB Secondary Prevention of Cirrhosis With Gastroesophageal Varices Bleeding
An observational study of Esophageal Varices Bleeding, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Varices Bleeding
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Mingkai Chen, doctor, 13720330580, kaimingchen@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Varices Bleeding
- Keywords
- Esophagogastric variceal hemorrhage, cirrhosis, secondary prevention, Non-selective beta blocker, compliance
- Medical subject headings
- Fibrosis, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Heart rate compliance ratio after treatment with NSBBs
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%).
Measured: 10 months
Secondary outcomes (2)
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
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
Measured: 10 months
The compliance of gastroscopy and bleeding of esophageal and gastric varices during the follow-up period were analyzed
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).
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Jul 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Varices BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChenMingkai, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683121
- Sponsor's protocol ID
- ChenMingkai
- Status last verified
- Mar 2021
- First submitted
- 15 Sep 2018
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Follow-up Methods on Compliance and Prognosis of NSBB Secondary Prevention of Cirrhosis With Gastroesophageal Varices Bleeding
- ClinicalTrials.gov ID
- NCT03683121
- Acronym / sponsor ID
- ChenMingkai
- Conditions
- Esophageal Varices Bleeding
- Keywords
- Esophagogastric variceal hemorrhage, cirrhosis, secondary prevention, Non-selective beta blocker, compliance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%).
2 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
Time frame: 10 months
The compliance of gastroscopy and bleeding of esophageal and gastric varices during the follow-up period were analyzed
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Varices Bleeding, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate compliance ratio after treatment with NSBBs (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.