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Trial record 3 of 9 for:    "Esophageal Disease" | "Terlipressin"

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

Tracking Information
First Submitted Date November 26, 2014
First Posted Date December 8, 2014
Last Update Posted Date December 8, 2014
Study Start Date February 2014
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 5, 2014)
The Change of Rebleeding Rate [ Time Frame: 1month, 3months, 6 months, 12 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 5, 2014)
  • Economic Cost [ Time Frame: up to 12 months ]
  • The Change of Quality of Life [ Time Frame: 1month, 3months, 6 months, 12 months ]
  • The Change of Survival Rate [ Time Frame: 1month, 3months, 6 months, 12 months ]
  • The Change of Complication Rate [ Time Frame: 1month, 3months, 6 months, 12 months ]
  • The Change of Drug Adverse Reaction Rate [ Time Frame: 1month, 3months, 6 months, 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails
Official Title Comparative Effectiveness Research: Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails to Treat the Patients With Acute Variceal Bleeding
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cirrohsis patients with acute variceal bleeding
Condition
  • Liver Cirrhosis
  • Esophageal and Gastric Varices
  • Hemorrhage
Intervention
  • 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
Study Groups/Cohorts
  • 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
    Interventions:
    • Drug: Usual Dose Somatostatin/Octreotide
    • Drug: High Dose Somatostatin/Octreotide
  • 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
    Interventions:
    • Drug: Terlipressin
    • Drug: Usual Dose Somatostatin/Octreotide
  • 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
    Interventions:
    • Drug: Terlipressin
    • Drug: Usual Dose Somatostatin/Octreotide
    • Drug: High Dose Somatostatin/Octreotide
  • 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
    Intervention: Drug: Usual Dose Somatostatin/Octreotide
  • Control: Initial Terlipressin
    Hemostasis achieved by an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h
    Intervention: Drug: Terlipressin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 5, 2014)
1320
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2016
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02311608
Other Study ID Numbers CSY-LB2-2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Shiyao Chen, Shanghai Zhongshan Hospital
Study Sponsor Shanghai Zhongshan Hospital
Collaborators Not Provided
Investigators
Study Chair: Shiyao Chen, Professor Shanghai Zhongshan Hospital
PRS Account Shanghai Zhongshan Hospital
Verification Date December 2014