Liver CirrhosisCER:TNCT02311608
Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails
An observational study of Liver Cirrhosis and Esophageal and Gastric Varices, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis, Esophageal and Gastric Varices, Hemorrhage
- What is being tested?
- Terlipressin, Usual Dose Somatostatin/Octreotide and High Dose Somatostatin/Octreotide
- Type of treatment
- Injection or infusion
- How many people
- 1,320 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cirrohsis patients with acute variceal bleeding
Who may be able to join
- Cirrhosis patients admitted to Emergency Department because of acute variceal bleeding
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Bing Li, Doctor, 86-18021057696, 07301010228@fudan.edu.cn
About this study
Official title: Comparative Effectiveness Research: Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails to Treat the Patients With Acute Variceal Bleeding
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.
Read the 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.
- Conditions
- Liver Cirrhosis, Esophageal and Gastric Varices, Hemorrhage
- Being tested
- Terlipressin, Usual Dose Somatostatin/Octreotide, High Dose Somatostatin/Octreotide
- Keywords
- acute variceal hemorrhage, terlipressin, somatostatin, octreotide, comparative effectiveness research
- Medical subject headings
- Liver Cirrhosis, Esophageal and Gastric Varices, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Also called Hanwei
administered as a first-line medicine or as salvage
Usual Dose Somatostatin/OctreotideDrug
Also called Yisuo/Shanning
administered as a first-line medicine or as salvage
High Dose Somatostatin/OctreotideDrug
Also called Yisuo/Shanning
administered as salvage
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change of Rebleeding Rate
Measured: 1month, 3months, 6 months, 12 months
Secondary outcomes (5)
Economic Cost
Measured: up to 12 months
The Change of Quality of Life
Measured: 1month, 3months, 6 months, 12 months
The Change of Survival Rate
Measured: 1month, 3months, 6 months, 12 months
The Change of Complication Rate
Measured: 1month, 3months, 6 months, 12 months
The Change of Drug Adverse Reaction Rate
Measured: 1month, 3months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyao Chen, Shanghai Zhongshan Hospital
- Investigators
- Shiyao Chen, Professor, Study chair, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311608
- Sponsor's protocol ID
- CSY-LB2-2014
- Acronym
- CER:T
- Status last verified
- Dec 2014
- First submitted
- 26 Nov 2014
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22178268Kalambokis 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.
PubMed 15955217Romero 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.
PubMed 10735611Lo 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.
PubMed 23278466Sola 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.
PubMed 20931555Abid 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.
PubMed 19223890Lo 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.
PubMed 19386609Fabrizi 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.
PubMed 16948805D'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.
PubMed 12730868Escorsell 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.
PubMed 10960437Baik 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.
PubMed 15743362Villanueva 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.
PubMed 15743361
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Research: Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails to Treat the Patients With Acute Variceal Bleeding
- ClinicalTrials.gov ID
- NCT02311608
- Acronym / sponsor ID
- CER:T / CSY-LB2-2014
- Conditions
- Liver Cirrhosis, Esophageal and Gastric Varices, Hemorrhage
- Keywords
- acute variceal hemorrhage, terlipressin, somatostatin, octreotide, comparative effectiveness research
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,320 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| High Dose Somatostatin/Octreotide | – | Drug: Usual Dose Somatostatin/Octreotide, Drug: High Dose Somatostatin/Octreotidecontinuous 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 |
| Terlipressin as salvage | – | Drug: Terlipressin, Drug: Usual Dose Somatostatin/Octreotidean 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 |
| Terlipr+usual dose somato/Octreo | – | Drug: Terlipressin, Drug: Usual Dose Somatostatin/Octreotide, Drug: High Dose Somatostatin/Octreotidean 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 |
| Control:Usual Dose Somato/Octreo | – | Drug: Usual Dose Somatostatin/OctreotideHemostasis achieved by continuous IV infusion of 250μg/h of Somatostatin or continuous IV infusion of 25μg/h of Octreotide |
| Control: Initial Terlipressin | – | Drug: TerlipressinHemostasis achieved by an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cirrohsis patients with acute variceal bleeding
Key inclusion criteria (1 listed)
- Cirrhosis patients admitted to Emergency Department because of acute variceal bleeding
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TerlipressinAlso: Hanweiadministered as a first-line medicine or as salvage | Drug | Control: Initial Terlipressin, Terlipr+usual dose somato/Octreo, Terlipressin as salvage |
| Usual Dose Somatostatin/OctreotideAlso: Yisuo/Shanningadministered as a first-line medicine or as salvage | Drug | Control:Usual Dose Somato/Octreo, High Dose Somatostatin/Octreotide, Terlipr+usual dose somato/Octreo, Terlipressin as salvage |
| High Dose Somatostatin/OctreotideAlso: Yisuo/Shanningadministered as salvage | Drug | High Dose Somatostatin/Octreotide, Terlipr+usual dose somato/Octreo |
Primary outcome
The Change of Rebleeding Rate
Time frame: 1month, 3months, 6 months, 12 months
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Background: PubMed 22178268Azam 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.
- Background: PubMed 15955217Kalambokis 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.
- Background: PubMed 10735611Romero 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.
- Background: PubMed 23278466Lo 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.
- Background: PubMed 20931555Sola 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.
- Background: PubMed 19223890Abid 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.
- Background: PubMed 19386609Lo 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.
- Background: PubMed 16948805Fabrizi 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.
- Background: PubMed 12730868D'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.
- Background: PubMed 10960437Escorsell 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.
- Results publication: PubMed 15743362Baik 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.
- Results publication: PubMed 15743361Villanueva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyao Chen, Professor study chair
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Esophageal and Gastric Varices, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiyao Chen, Professor (86-13701761310, chen.shiyao@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change of Rebleeding Rate (time frame: 1month, 3months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02311608, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.