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

NCT ID: NCT00108355

Last Updated: 2014-03-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2012-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Ascites Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Albumin (Control group)

After LVP, patients in this group received:

Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)

Group Type ACTIVE_COMPARATOR

Albumin

Intervention Type DRUG

Intravenous Albumin at a dose of 8g/liter of ascitic fluid removed

Oral tablet (Midodrine placebo)

Intervention Type DRUG

Oral tablet (Midodrine placebo) three times a day

Saline injection (Octreotide LAR placebo)

Intervention Type DRUG

Saline intramuscular injection 5 cc every 30 days.

Large Volume Paracentesis

Intervention Type PROCEDURE

Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.

Vasoconstrictor (Study Group)

After LVP, patients in this group received:

Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose

Group Type EXPERIMENTAL

Intravenous Saline Infusion (Albumin placebo)

Intervention Type DRUG

Intravenous saline Infusion (Albumin placebo)

Midodrine

Intervention Type DRUG

Midodrine oral tablet at 10 mg three times a day.

Octreotide LAR

Intervention Type DRUG

Octreotide LAR 20 mg intramuscular injection every 30 days

Large Volume Paracentesis

Intervention Type PROCEDURE

Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.

Interventions

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Albumin

Intravenous Albumin at a dose of 8g/liter of ascitic fluid removed

Intervention Type DRUG

Intravenous Saline Infusion (Albumin placebo)

Intravenous saline Infusion (Albumin placebo)

Intervention Type DRUG

Midodrine

Midodrine oral tablet at 10 mg three times a day.

Intervention Type DRUG

Oral tablet (Midodrine placebo)

Oral tablet (Midodrine placebo) three times a day

Intervention Type DRUG

Octreotide LAR

Octreotide LAR 20 mg intramuscular injection every 30 days

Intervention Type DRUG

Saline injection (Octreotide LAR placebo)

Saline intramuscular injection 5 cc every 30 days.

Intervention Type DRUG

Large Volume Paracentesis

Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.

Intervention Type PROCEDURE

Other Intervention Names

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LVP

Eligibility Criteria

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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)
* Serum creatinine \> 3 mg/dl
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guadalupe Garcia-Tsao, MD

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Health Care System (West Haven)

Locations

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VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Karwa R, Woodis CB. Midodrine and octreotide in treatment of cirrhosis-related hemodynamic complications. Ann Pharmacother. 2009 Apr;43(4):692-9. doi: 10.1345/aph.1L373. Epub 2009 Mar 18.

Reference Type BACKGROUND
PMID: 19299324 (View on PubMed)

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.

Reference Type RESULT
PMID: 22095893 (View on PubMed)

Moreau R, Asselah T, Condat B, de Kerguenec C, Pessione F, Bernard B, Poynard T, Binn M, Grange 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. doi: 10.1136/gut.50.1.90.

Reference Type RESULT
PMID: 11772973 (View on PubMed)

Lata J, Marecek Z, Fejfar T, Zdenek P, Bruha R, Safka V, Hulek P, Hejda V, Dolina J, Stehlik 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.

Reference Type RESULT
PMID: 18251131 (View on PubMed)

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. doi: 10.1002/hep.510290629.

Reference Type RESULT
PMID: 10347109 (View on PubMed)

Bari K, Minano C, Shea M, Inayat IB, Hashem HJ, Gilles H, Heuman D, Garcia-Tsao G. The combination of octreotide and midodrine is not superior to albumin in preventing recurrence of ascites after large-volume paracentesis. Clin Gastroenterol Hepatol. 2012 Oct;10(10):1169-75. doi: 10.1016/j.cgh.2012.06.027. Epub 2012 Jul 16.

Reference Type RESULT
PMID: 22801062 (View on PubMed)

Appenrodt B, Wolf A, Grunhage 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. doi: 10.1111/j.1478-3231.2008.01734.x. Epub 2008 Apr 11.

Reference Type RESULT
PMID: 18410283 (View on PubMed)

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. doi: 10.1111/j.1572-0241.2008.01787.x.

Reference Type RESULT
PMID: 18547224 (View on PubMed)

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. doi: 10.1111/j.1478-3231.2008.01778.x. Epub 2008 May 19.

Reference Type RESULT
PMID: 18492024 (View on PubMed)

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. doi: 10.1111/j.1440-1746.2006.04182.x.

Reference Type RESULT
PMID: 16460491 (View on PubMed)

Other Identifiers

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CLIN-016-03F

Identifier Type: -

Identifier Source: org_study_id

NCT00530959

Identifier Type: -

Identifier Source: nct_alias

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