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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00986817
First received: September 29, 2009
Last updated: October 7, 2014
Last verified: October 2014

September 29, 2009
October 7, 2014
November 2009
March 2015   (final data collection date for primary outcome measure)
Mean number of paracentesis between the 2 groups over a 6 months period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00986817 on ClinicalTrials.gov Archive Site
  • Total ascites retrieval [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Number of cirrhosis complications groups [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Liver transplantation and deaths [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Terlipressin safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Mean number of days of hospitalization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Delay between inclusion and the first rehospitalisation for ascites retrieval [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Terlipressin in Cirrhotic Patients With Recidivation Ascites Treated With Paracentesis and Albumin
Efficacy of Terlipressin in Cirrhotic Patients With Recidivation Ascites Treated With Paracentesis and Albumin. A Multi-center Randomized Controlled Study

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cirrhosis
  • 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.
    Other Name: Terlipressin
  • Drug: Placebo
    albumin perfusion at the dose 8 g/l of removed ascites and placebo, administrated before and at the end of the paracentesis.
    Other Name: Placebo
  • Experimental: Terlipressin
    Intervention: Drug: Terlipressin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
82
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00986817
P071215
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Nicolas Carbonell, MD Hôpital Saint Antoine
Assistance Publique - Hôpitaux de Paris
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP