Vasoconstrictors as Alternatives to Albumin After LVP (Large-Volume Paracentesis) in Cirrhosis - Full Text View

Purpose

This clinical trial compares a combination of two drugs that constrict blood vessels (Sandostatin LAR and Midodrine) to albumin after large volume paracentesis. Subjects have cirrhosis and ascites.

Condition	Intervention	Phase
Ascites Cirrhosis	Drug: albumin Drug: octreotide plus midodrine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Vasoconstrictors as Alternatives to Albumin After LVP in Cirrhosis

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

Drug Information available for: Midodrine hydrochloride Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

The analysis of the primary endpoint, time to recurrence of ascites, will be according to the principal of intention to treat. The primary treatment comparison will be patients randomized to LVP+vasoconstrictors vs LVP + albumen. [ Time Frame: Variable depending on the patient ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	December 2003
Study Completion Date:	June 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 LVP+albumin+placebo midodrine+placebo octreotide	Drug: albumin LVP + albumin placebo+midodrine+octreotide
Placebo Comparator: Arm 2 LVP + albumin placebo+midodrine+octreotide	Drug: octreotide plus midodrine LVP+albumin+placebo midodrine+placebo octreotide

Detailed Description:

This prospective, placebo-controlled, randomized, clinical trial compares the effect of a combination of vasoconstrictors (octreotide plus midodrine) to albumin on the time to recurrence of ascites in patients with refractory ascites treated with large volume paracentesis. The treatment allocation ratio for the two treatment arms is 1:1 using a stratified random permuted block design. Subjects are patients 18-80 years old with cirrhosis and ascites who are stratified according to the presence or absence of renal dysfunction at the time of randomization. Measurements include blood pressure, weight, girth, abdominal ultrasound, forearm blood flow, plasma renin activity, angiotensin, and aldosterone, repeated during a 6 month period.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cirrhosis of any etiology
Age 18-80 years
Moderate to severe ascites

Exclusion Criteria:

No or small ascites
Severe hepatic hydrothorax
Recent GI (gastrointestinal) hemorrhage
Active bacterial infection
Cardiac failure
Organic renal disease
Hepatocellular carcinoma
Severe comorbidity (advanced neoplasia)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108355

Locations

United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Guadalupe Garcia-Tsao, MD

VA Connecticut Health Care System (West Haven)

More Information

Publications:

Appenrodt B, Wolf A, Grünhage F, Trebicka J, Schepke M, Rabe C, Lammert F, Sauerbruch T, Heller J. Prevention of paracentesis-induced circulatory dysfunction: midodrine vs albumin. A randomized pilot study. Liver Int. 2008 Aug;28(7):1019-25. Epub 2008 Apr 11.

Singh V, Dheerendra PC, Singh B, Nain CK, Chawla D, Sharma N, Bhalla A, Mahi SK. Midodrine versus albumin in the prevention of paracentesis-induced circulatory dysfunction in cirrhotics: a randomized pilot study. Am J Gastroenterol. 2008 Jun;103(6):1399-405.

Tandon P, Tsuyuki RT, Mitchell L, Hoskinson M, Ma MM, Wong WW, Mason AL, Gutfreund K, Bain VG. The effect of 1 month of therapy with midodrine, octreotide-LAR and albumin in refractory ascites: a pilot study. Liver Int. 2009 Feb;29(2):169-74. Epub 2008 May 19.

Singh V, Kumar R, Nain CK, Singh B, Sharma AK. Terlipressin versus albumin in paracentesis-induced circulatory dysfunction in cirrhosis: a randomized study. J Gastroenterol Hepatol. 2006 Jan;21(1 Pt 2):303-7.

Bernardi M, Caraceni P, Navickis RJ, Wilkes MM. Albumin infusion in patients undergoing large-volume paracentesis: a meta-analysis of randomized trials. Hepatology. 2012 Apr;55(4):1172-81. doi: 10.1002/hep.24786.

Moreau R, Asselah T, Condat B, de Kerguenec C, Pessione F, Bernard B, Poynard T, Binn M, Grangé JD, Valla D, Lebrec D. Comparison of the effect of terlipressin and albumin on arterial blood volume in patients with cirrhosis and tense ascites treated by paracentesis: a randomised pilot study. Gut. 2002 Jan;50(1):90-4.

Lata J, Marecek Z, Fejfar T, Zdenek P, Brůha R, Safka V, Hůlek P, Hejda V, Dolina J, Stehlík J, Tozzi I. The efficacy of terlipressin in comparison with albumin in the prevention of circulatory changes after the paracentesis of tense ascites--a randomized multicentric study. Hepatogastroenterology. 2007 Oct-Nov;54(79):1930-3.

Angeli P, Volpin R, Gerunda G, Craighero R, Roner P, Merenda R, Amodio P, Sticca A, Caregaro L, Maffei-Faccioli A, Gatta A. Reversal of type 1 hepatorenal syndrome with the administration of midodrine and octreotide. Hepatology. 1999 Jun;29(6):1690-7.

Karwa R, Woodis CB. Midodrine and octreotide in treatment of cirrhosis-related hemodynamic complications. Ann Pharmacother. 2009 Apr;43(4):692-9. Epub 2009 Mar 18. Review.

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00108355 History of Changes
Other Study ID Numbers:	CLIN-016-03F
Study First Received:	April 14, 2005
Last Updated:	April 1, 2013
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

albumin
ascites
paracentesis

Additional relevant MeSH terms:

Ascites
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Midodrine
Vasoconstrictor Agents
Octreotide
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 22, 2013