Clinical trial NCT02311608: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Esophageal and Gastric Varices
Hemorrhage
Keywords: acute variceal hemorrhage
terlipressin
somatostatin
octreotide
comparative effectiveness research
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 1320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrohsis 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.

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

Primary outcomes:
measure: The Change of Rebleeding Rate
timeFrame: 1month, 3months, 6 months, 12 months
Secondary outcomes:
measure: Economic Cost
timeFrame: up to 12 months
measure: The Change of Quality of Life
timeFrame: 1month, 3months, 6 months, 12 months
measure: The Change of Survival Rate
timeFrame: 1month, 3months, 6 months, 12 months
measure: The Change of Complication Rate
timeFrame: 1month, 3months, 6 months, 12 months
measure: The Change of Drug Adverse Reaction Rate
timeFrame: 1month, 3months, 6 months, 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Shiyao Chen, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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. doi: 10.1111/j.1440-1746.2005.03902.x.
citation: 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. doi: 10.1016/s0168-8278(00)80392-x.
citation: 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.
citation: Sola E, Lens S, Guevara M, Martin-Llahi M, Fagundes C, Pereira G, Pavesi M, Fernandez J, Gonzalez-Abraldes J, Escorsell A, Mas A, Bosch J, Arroyo V, Gines 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.
citation: 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.
citation: 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.
citation: Fabrizi F, Dixit V, Martin P. Meta-analysis: terlipressin therapy for the hepatorenal syndrome. Aliment Pharmacol Ther. 2006 Sep 15;24(6):935-44. doi: 10.1111/j.1365-2036.2006.03086.x.
citation: 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. doi: 10.1016/s0016-5085(03)00269-5.
citation: Escorsell A, Ruiz del Arbol L, Planas R, Albillos A, Banares R, Cales 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. doi: 10.1053/jhep.2000.16601.
citation: Baik SK, Jeong PH, Ji SW, Yoo BS, Kim HS, Lee DK, Kwon SO, Kim YJ, Park JW, Chang SJ, Lee SS. Acute hemodynamic effects of octreotide and terlipressin in patients with cirrhosis: a randomized comparison. Am J Gastroenterol. 2005 Mar;100(3):631-5. doi: 10.1111/j.1572-0241.2005.41381.x.
citation: Villanueva 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.