CER:T: Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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:
Drug: High Dose Somatostatin/Octreotide
administered as salvage
Other Names:
|
| 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 Names:
Drug: Usual Dose Somatostatin/Octreotide
administered as a first-line medicine or as salvage
Other Names:
|
| 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 Names:
Drug: Usual Dose Somatostatin/Octreotide
administered as a first-line medicine or as salvage
Other Names:
Drug: High Dose Somatostatin/Octreotide
administered as salvage
Other Names:
|
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- The Change of Rebleeding Rate [1month, 3months, 6 months, 12 months]
Secondary Outcome Measures
- Economic Cost [up to 12 months]
- The Change of Quality of Life [1month, 3months, 6 months, 12 months]
- The Change of Survival Rate [1month, 3months, 6 months, 12 months]
- The Change of Complication Rate [1month, 3months, 6 months, 12 months]
- The Change of Drug Adverse Reaction Rate [1month, 3months, 6 months, 12 months]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Hospital | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
Investigators
- Study Chair: Shiyao Chen, Professor, Shanghai Zhongshan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Abid S, Jafri W, Hamid S, Salih M, Azam Z, Mumtaz K, Shah HA, Abbas Z. Terlipressin vs. octreotide in bleeding esophageal varices as an adjuvant therapy with endoscopic band ligation: a randomized double-blind placebo-controlled trial. Am J Gastroenterol. 2009 Mar;104(3):617-23. doi: 10.1038/ajg.2008.147. Epub 2009 Feb 17.
- Azam Z, Hamid S, Jafri W, Salih M, Abbas Z, Abid S, Shah H. Short course adjuvant terlipressin in acute variceal bleeding: a randomized double blind dummy controlled trial. J Hepatol. 2012 Apr;56(4):819-24. doi: 10.1016/j.jhep.2011.11.019. Epub 2011 Dec 16.
- D'Amico G, Pietrosi G, Tarantino I, Pagliaro L. Emergency sclerotherapy versus vasoactive drugs for variceal bleeding in cirrhosis: a Cochrane meta-analysis. Gastroenterology. 2003 May;124(5):1277-91.
- Escorsell A, Ruiz del Arbol L, Planas R, Albillos A, Bañares R, Calès P, Pateron D, Bernard B, Vinel JP, Bosch J. Multicenter randomized controlled trial of terlipressin versus sclerotherapy in the treatment of acute variceal bleeding: the TEST study. Hepatology. 2000 Sep;32(3):471-6.
- Fabrizi F, Dixit V, Martin P. Meta-analysis: terlipressin therapy for the hepatorenal syndrome. Aliment Pharmacol Ther. 2006 Sep 15;24(6):935-44. Review.
- Kalambokis G, Economou M, Paraskevi K, Konstantinos P, Pappas C, Katsaraki A, Tsianos EV. Effects of somatostatin, terlipressin and somatostatin plus terlipressin on portal and systemic hemodynamics and renal sodium excretion in patients with cirrhosis. J Gastroenterol Hepatol. 2005 Jul;20(7):1075-81.
- Lo GH, Chen WC, Wang HM, Lin CK, Chan HH, Tsai WL, Cheng LC, Yu HC, Tsay FW. Low-dose terlipressin plus banding ligation versus low-dose terlipressin alone in the prevention of very early rebleeding of oesophageal varices. Gut. 2009 Sep;58(9):1275-80. doi: 10.1136/gut.2008.165910. Epub 2009 Apr 21.
- Lo GH, Perng DS, Chang CY, Tai CM, Wang HM, Lin HC. Controlled trial of ligation plus vasoconstrictor versus proton pump inhibitor in the control of acute esophageal variceal bleeding. J Gastroenterol Hepatol. 2013 Apr;28(4):684-9. doi: 10.1111/jgh.12107.
- Romero G, Kravetz D, Argonz J, Bildozola M, Suarez A, Terg R. Terlipressin is more effective in decreasing variceal pressure than portal pressure in cirrhotic patients. J Hepatol. 2000 Mar;32(3):419-25.
- Solà E, Lens S, Guevara M, Martín-Llahí M, Fagundes C, Pereira G, Pavesi M, Fernández J, González-Abraldes J, Escorsell A, Mas A, Bosch J, Arroyo V, Ginès P. Hyponatremia in patients treated with terlipressin for severe gastrointestinal bleeding due to portal hypertension. Hepatology. 2010 Nov;52(5):1783-90. doi: 10.1002/hep.23893.
- CSY-LB2-2014