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Terlipressin in Cirrhotic Patients With Recidivation Ascites Treated With Paracentesis and Albumin (TERAS)

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ClinicalTrials.gov Identifier: NCT00986817
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Ascites is a common complication of cirrhosis. Sodium restriction and diuretics are the first step treatment. Refractory ascites (not responding to first step treatment) is treated with repeated large volume paracentesis followed by intra venous albumin expansion. In pilot studies vasoconstrictor agents such as terlipressin have shown beneficial effect on ascites production. Therefore the investigators will study the effect of combined therapy with albumin and terlipressin on recidivation ascites.

Condition or disease Intervention/treatment Phase
Cirrhosis Drug: Terlipressin Drug: Placebo Phase 3

Detailed Description:
About 30% of cirrhotic patients will develop ascites. Sodium restriction and diuretics are the first step treatment. Total paracentesis is used in patients with cirrhosis and tense ascites. Paracentesis alone was found to induce a decrease in effective arterial blood volume. This circulatory dysfunction may induce inhospital complications such as impaired renal function or hyponatremia and is associated with a significant reduction in long term survival. Intravenous albumin administration after paracentesis has been shown to prevent the post paracentesis decrease in arterial blood volume. Paracentesis also induces arteriolar vasodilation which plays a major role in initiating the decrease in arterial blood volume. Therefore, administration of a vasoconstrictor may decrease paracentesis induced arteriolar vasodilation and prevent the resulting decrease in effective arterial blood volume. Two randomised pilot studies suggest that Terlipressin may be as effective as intravenous albumin in preventing a decrease in effective arterial blood volume in patients with cirrhosis treated by paracentesis for tense ascites. The combined treatment, albumin plus terlipressin, could have additional effect and may improve ascites in such patients. In several studies the combined therapy, albumin plus terlipressin, has shown beneficial effect in cirrhotic patients with hepatorenal syndrome characterized by a sever decrease in arterial blood volume and vasodilation. In these studies, combined therapy was well tolerated.The aim of this study is to compare ascites relapse between two groups of cirrhotic patients with recidivation ascites treated by paracentesis and intravenous albumin perfusion plus terlipressin or placebo. In this double blind randomized multi-center trial, all patients receive albumin perfusion at the dose 8 g/l of removed ascites and Terlipressin (1mg) or placebo, administrated before and at the end of the paracentesis.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Terlipressin in Cirrhotic Patients With Recidivation Ascites Treated With Paracentesis and Albumin. A Multi-center Randomized Controlled Study
Study Start Date : November 2009
Primary Completion Date : March 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Terlipressin Drug: Terlipressin
Albumin perfusions at the dose 8 g/l of removed ascites and Terlipressin (1mg), administrated before and at the end of the paracentesis.
Placebo Comparator: Placebo Drug: Placebo
albumin perfusion at the dose 8 g/l of removed ascites and placebo, administrated before and at the end of the paracentesis.


Outcome Measures

Primary Outcome Measures :
  1. Mean number of paracentesis between the 2 groups over a 6 months period [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Total ascites retrieval [ Time Frame: 6 months ]
  2. Number of cirrhosis complications groups [ Time Frame: 6 months ]
  3. Liver transplantation and deaths [ Time Frame: 6 months ]
  4. Terlipressin safety [ Time Frame: 6 months ]
  5. Mean number of days of hospitalization [ Time Frame: 6 months ]
  6. Delay between inclusion and the first rehospitalisation for ascites retrieval [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient aged 18 years old and more with cirrhosis and refractory ascites define by the international ascites club.
  • Vital status non engaged in the 2 months

Exclusion Criteria:

  • cardiovascular disease : previous or actual angina pectoralis, myocardial infarction, heart failure, rhythm or conduction disorders, repolarisation abnormality on ECG
  • respiratory disease: previous or actual chronic pulmonary insufficiency, asthma
  • uncontrolled hypertension
  • acute portal vein thrombosis (less then 3 months) or currently treated.
  • chronic renal insufficiency (creatin > 15 mg/L)
  • severe hepatic encephalopathy
  • Alcoholic hepatitis or gastrointestinal bleeding in the last 3 months
  • hepatocellular carcinoma
  • severe illness with life threatening
  • pregnant or breastfeeding women
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986817


Locations
France
CARBONELL Nicolas
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Nicolas Carbonell, MD Hôpital Saint Antoine
More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00986817     History of Changes
Other Study ID Numbers: P071215
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: June 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Refractory ascites
Cirrhosis Terlipressin
Paracentesis

Additional relevant MeSH terms:
Fibrosis
Ascites
Pathologic Processes
Terlipressin
Lypressin
Antihypertensive Agents
Vasoconstrictor Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs