Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails (CER:T)

December 5, 2014 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

Comparative Effectiveness Research: Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails to Treat the Patients With Acute Variceal Bleeding

To observe and access the Effects and safety of terlipressin or high dose somatostatin/octreotide when usual dose somatostatin/octreotide fail to achieve hemostasis in patients with acute variceal bleeding.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The prognosis information of the patients with acute variceal bleeding will be collected, including hemostasis rate, early rebleeding rate, mortality, complications, severity adverse events, economic burdens and quality of life, when terlipressin or high dose somatostatin/octreotide is used as salvation to patients fail to achieve initial hemostasis.The results may help gastroenterologists to make decisions when administering vasoactive medicines to those suffered from acute variceal bleeding.

Study Type

Observational

Enrollment (Anticipated)

1320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cirrohsis patients with acute variceal bleeding

Description

Inclusion Criteria:

  • Cirrhosis patients admitted to Emergency Department because of acute variceal bleeding

Exclusion Criteria:

  • No signs of variceal bleeding are found by endoscopy or portal hypertensive gastropathy is responsible for the bleeding
  • Patients undergo endoscopy after 72h from the beginning of acute variceal bleeding
  • Patients with hepatorenal syndrome
  • Patients with ischemia organic cardiopathy (including myocardial infarction or unstable angina pectoris) or myocardial ischemia indicated by ECG in the past 6 months
  • Patients allergic to/with contraindications of vasoactive drugs

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High Dose Somatostatin/Octreotide
continuous IV infusion of 500μg/h of Somatostatin or continuous IV infusion of 50μg/h of Octreotide when usual somatostatin or Octreotide dose fails to achieve hemostasis of acute variceal bleeding patients
Drug: Usual Dose Somatostatin/Octreotide
administered as a first-line medicine or as salvage
Other Names:
  • Yisuo/Shanning
Drug: High Dose Somatostatin/Octreotide
administered as salvage
Other Names:
  • Yisuo/Shanning
Terlipressin as salvage
an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h when usual somatostatin or Octreotide dose fails to achieve hemostasis of acute variceal bleeding patients
Drug: Usual Dose Somatostatin/Octreotide
administered as a first-line medicine or as salvage
Other Names:
  • Yisuo/Shanning
Drug: Terlipressin
administered as a first-line medicine or as salvage
Other Names:
  • Hanwei
Terlipr+usual dose somato/Octreo
an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h together with continuous IV infusion of 250μg/h of Somatostatin or continuous IV infusion of 25μg/h of Octreotide when usual somatostatin or Octreotide dose fails to achieve hemostasis of acute variceal bleeding patients
Drug: Usual Dose Somatostatin/Octreotide
administered as a first-line medicine or as salvage
Other Names:
  • Yisuo/Shanning
Drug: High Dose Somatostatin/Octreotide
administered as salvage
Other Names:
  • Yisuo/Shanning
Drug: Terlipressin
administered as a first-line medicine or as salvage
Other Names:
  • Hanwei
Control:Usual Dose Somato/Octreo
Hemostasis achieved by continuous IV infusion of 250μg/h of Somatostatin or continuous IV infusion of 25μg/h of Octreotide
Drug: Usual Dose Somatostatin/Octreotide
administered as a first-line medicine or as salvage
Other Names:
  • Yisuo/Shanning
Control: Initial Terlipressin
Hemostasis achieved by an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h
Drug: Terlipressin
administered as a first-line medicine or as salvage
Other Names:
  • Hanwei

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Change of Rebleeding Rate
Time Frame: 1month, 3months, 6 months, 12 months
1month, 3months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Economic Cost
Time Frame: up to 12 months
up to 12 months
The Change of Quality of Life
Time Frame: 1month, 3months, 6 months, 12 months
1month, 3months, 6 months, 12 months
The Change of Survival Rate
Time Frame: 1month, 3months, 6 months, 12 months
1month, 3months, 6 months, 12 months
The Change of Complication Rate
Time Frame: 1month, 3months, 6 months, 12 months
1month, 3months, 6 months, 12 months
The Change of Drug Adverse Reaction Rate
Time Frame: 1month, 3months, 6 months, 12 months
1month, 3months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Study Chair: Shiyao Chen, Professor, Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2014

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSY-LB2-2014

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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