Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails

NCT02311608 | Unknown DMC

• 1 other identifier: CSY-LB2-2014
• Study Type: observational
• Target: 1,320
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Esophageal and Gastric Varices; Hemorrhage

Keywords

acute variceal hemorrhage; terlipressin; somatostatin; octreotide; comparative effectiveness research

Outcome Measures

Primary Outcomes (1)

• The Change of Rebleeding Rate

  1month, 3months, 6 months, 12 months

Secondary Outcomes (5)

• 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

Study Arms (5)

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; 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

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

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

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

Drug: Terlipressin

Interventions

Terlipressin DRUG

administered as a first-line medicine or as salvage

Also known as: Hanwei

Control: Initial Terlipressin; Terlipr+usual dose somato/Octreo; Terlipressin as salvage

Usual Dose Somatostatin/Octreotide DRUG

administered as a first-line medicine or as salvage

Also known as: Yisuo/Shanning

Control:Usual Dose Somato/Octreo; High Dose Somatostatin/Octreotide; Terlipr+usual dose somato/Octreo; Terlipressin as salvage

High Dose Somatostatin/Octreotide DRUG

administered as salvage

Also known as: Yisuo/Shanning

High Dose Somatostatin/Octreotide; Terlipr+usual dose somato/Octreo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cirrohsis patients with acute variceal bleeding

You may qualify if:

• Cirrhosis patients admitted to Emergency Department because of acute variceal bleeding

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 22178268 BACKGROUND

• 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.

  PMID: 15955217 BACKGROUND

• 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.

  PMID: 10735611 BACKGROUND

• 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.

  PMID: 23278466 BACKGROUND

• 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.

  PMID: 20931555 BACKGROUND

• 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.

  PMID: 19223890 BACKGROUND

• 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.

  PMID: 19386609 BACKGROUND

• 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.

  PMID: 16948805 BACKGROUND

• 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.

  PMID: 12730868 BACKGROUND

• 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.

  PMID: 10960437 BACKGROUND

• 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.

  PMID: 15743362 RESULT

• 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.

  PMID: 15743361 RESULT

MeSH Terms

Conditions

Liver Cirrhosis; Esophageal and Gastric Varices; Hemorrhage

Interventions

Terlipressin; Octreotide; Somatostatin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Hypertension, Portal

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Pancreatic Hormones

Study Officials

• Shiyao Chen, Professor

  Shanghai Zhongshan Hospital

  STUDY CHAIR

Central Study Contacts

Shiyao Chen, Professor

CONTACT

86-13701761310; chen.shiyao@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department fo Gastroenterology, Zhongshan Hospital

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 8, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

CN (1)