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

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ClinicalTrials.gov Identifier: NCT02311608
Recruitment Status : Unknown
Verified December 2014 by Shiyao Chen, Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Shiyao Chen, Shanghai Zhongshan Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Liver Cirrhosis Esophageal and Gastric Varices Hemorrhage Drug: Terlipressin Drug: Usual Dose Somatostatin/Octreotide Drug: High Dose Somatostatin/Octreotide

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.

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Study Type : Observational
Estimated Enrollment : 1320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Effectiveness Research: Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails to Treat the Patients With Acute Variceal Bleeding
Study Start Date : February 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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 Name: Yisuo/Shanning

Drug: High Dose Somatostatin/Octreotide
administered as salvage
Other Name: 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: Terlipressin
administered as a first-line medicine or as salvage
Other Name: Hanwei

Drug: Usual Dose Somatostatin/Octreotide
administered as a first-line medicine or as salvage
Other Name: Yisuo/Shanning

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: Terlipressin
administered as a first-line medicine or as salvage
Other Name: Hanwei

Drug: Usual Dose Somatostatin/Octreotide
administered as a first-line medicine or as salvage
Other Name: Yisuo/Shanning

Drug: High Dose Somatostatin/Octreotide
administered as salvage
Other Name: Yisuo/Shanning

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 Name: 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 Name: Hanwei




Primary Outcome Measures :
  1. The Change of Rebleeding Rate [ Time Frame: 1month, 3months, 6 months, 12 months ]

Secondary Outcome Measures :
  1. Economic Cost [ Time Frame: up to 12 months ]
  2. The Change of Quality of Life [ Time Frame: 1month, 3months, 6 months, 12 months ]
  3. The Change of Survival Rate [ Time Frame: 1month, 3months, 6 months, 12 months ]
  4. The Change of Complication Rate [ Time Frame: 1month, 3months, 6 months, 12 months ]
  5. The Change of Drug Adverse Reaction Rate [ Time Frame: 1month, 3months, 6 months, 12 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cirrohsis patients with acute variceal bleeding
Criteria

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

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): NCT02311608


Contacts
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Contact: Shiyao Chen, Professor 86-13701761310 chen.shiyao@zs-hospital.sh.cn

Locations
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China, Shanghai
Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Bing Li, Doctor    86-18021057696    07301010228@fudan.edu.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Chair: Shiyao Chen, Professor Shanghai Zhongshan Hospital

Publications of Results:
Other Publications:

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Responsible Party: Shiyao Chen, Director of department fo Gastroenterology, Zhongshan Hospital, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02311608     History of Changes
Other Study ID Numbers: CSY-LB2-2014
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Shiyao Chen, Shanghai Zhongshan Hospital:
acute variceal hemorrhage
terlipressin
somatostatin
octreotide
comparative effectiveness research
Additional relevant MeSH terms:
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Liver Cirrhosis
Esophageal and Gastric Varices
Hemorrhage
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal
Octreotide
Terlipressin
Somatostatin
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antihypertensive Agents
Vasoconstrictor Agents