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Trial · Observational

Status unknownPhase not statedRegistry data

Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails

Short name CER:T

NCTNCT02311608 (opens ClinicalTrials.gov in a new tab)Other idCSY-LB2-2014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase not stated
Enrollment
1,320 participants (estimated)
Sponsor
Shanghai Zhongshan Hospital · Other
Design
Not stated
Countries
1 country

China

Start
Feb 2014
Primary completion
Feb 2016 (estimated)
Completion
Jun 2016 (estimated)
First posted
8 Dec 2014 (estimated)
Last update posted
8 Dec 2014 (estimated)
Conditions
Liver Cirrhosis · Esophageal and Gastric Varices · Hemorrhage

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017
  1. Ph –

    CER:T

    NCT02311608

    Feb 2014 to est. Jun 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TerlipressinDrug
  • Usual Dose Somatostatin/OctreotideDrug
  • High Dose Somatostatin/OctreotideDrug

Arms5

  • Other

    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

  • Other

    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

  • Other

    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

  • Other

    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

  • Other

    Control: Initial Terlipressin

    Hemostasis achieved by an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The Change of Rebleeding Rate

    Time frame · 1month, 3months, 6 months, 12 months

Secondary outcomes(5)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2009

5 results

Terlipressin vs. octreotide in bleeding esophageal varices as an adjuvant therapy with endoscopic band ligation: a randomized double-blind placebo-controlled trial.

Abid et al. 2009The American journal of gastroenterologycited by 52

PMID 19223890DOI 10.1038/ajg.2008.147PUB-19223890

Full text at the publisher5 results
Publisher pageSee results (5)

Indexing hint: Randomized controlled trial · 2005

6 results

Acute hemodynamic effects of octreotide and terlipressin in patients with cirrhosis: a randomized comparison.

Baik et al. 2005The American journal of gastroenterologycited by 83

PMID 15743362DOI 10.1111/j.1572-0241.2005.41381.xPUB-15743362

Full text at the publisher6 results
Publisher pageSee results (6)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultVillanueva C, Planella M, Aracil C, Lopez-Balaguer JM, Gonzalez B, Minana J, Balanzo J. Hemodynamic effects of terlipressin and high somatostatin dose during acute variceal bleeding in nonresponders to the usual somatostatin dose. Am J Gastroenterol. 2005 Mar;100(3):624-30. doi: 10.1111/j.1572-0241.2004.40665.x. PMID 15743361

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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