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AscitesPhase 4NCT00108355

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

A Phase 4 study testing Albumin, Midodrine and Octreotide LAR in people with Ascites and Cirrhosis, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ascites, Cirrhosis
What is being tested?
Albumin, Midodrine and Octreotide LAR
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
29 participants
Where
1 siteUnited States
Study dates
Dec 2003to Aug 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • No or small ascites
  • Severe hepatic hydrothorax
  • Recent GI (gastrointestinal) hemorrhage
  • Active bacterial infection
  • Cardiac failure
  • Organic renal disease
Show all 10Show fewer
  • Hepatocellular carcinoma
  • Severe comorbidity (advanced neoplasia)
  • Serum creatinine > 3 mg/dl
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Connecticut Health Care System (West Haven)

    West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: Vasoconstrictors as Alternatives to Albumin After Large Volume Paracentesis in Cirrhosis

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.

Read the 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.

Conditions
Ascites, Cirrhosis
Being tested
Albumin, Intravenous Saline Infusion (Albumin placebo), Midodrine, Oral tablet (Midodrine placebo), Octreotide LAR
Keywords
albumin, ascites, paracentesis
Medical subject headings
Ascites, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlbuminDrug

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

  • Intravenous Saline Infusion (Albumin placebo)Drug

    Intravenous saline Infusion (Albumin placebo)

  • MidodrineDrug

    Midodrine oral tablet at 10 mg three times a day.

  • Oral tablet (Midodrine placebo)Drug

    Oral tablet (Midodrine placebo) three times a day

  • Octreotide LARDrug

    Octreotide LAR 20 mg intramuscular injection every 30 days

  • Saline injection (Octreotide LAR placebo)Drug

    Saline intramuscular injection 5 cc every 30 days.

  • Large Volume ParacentesisProcedure or surgery

    Also called LVP

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

Study groups in NCT00108355
Study groupRoleWhat they receive
Albumin (Control group)Active comparatorAfter 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)
Receives: Drug: Albumin; Drug: Oral tablet (Midodrine placebo); Drug: Saline injection (Octreotide LAR placebo); Procedure: Large Volume Paracentesis
Vasoconstrictor (Study Group)ExperimentalAfter 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
Receives: Drug: Intravenous Saline Infusion (Albumin placebo); Drug: Midodrine; Drug: Octreotide LAR; Procedure: Large Volume Paracentesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Recurrence of Ascites.

    Comparison between Albumin (Control group) and Vasoconstrictor (Treatment group)

    Measured: Variable depending on the patient, average 10 days

Secondary outcomes (1)

  1. Development of Post-paracentesis Circulatory Dysfunction (PCD)

    Defined as an increase in Plasma Renin Activity (PRA) by >50% from baseline to a level > 4 ng/mL/h at post-paracentesis day

    Measured: 6 days after paracentesis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2005 (estimated)
  2. Study startDec 2003
  3. Primary completionAug 2010
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00108355
Sponsor's protocol ID
CLIN-016-03F
Status last verified
Feb 2014
First submitted
14 Apr 2005
Last updated
6 Mar 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19299324

  • 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.

    PubMed 22095893

  • 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.

    PubMed 11772973

  • 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.

    PubMed 18251131

  • 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.

    PubMed 10347109

  • 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.

    PubMed 22801062

  • 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.

    PubMed 18410283

  • 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.

    PubMed 18547224

  • 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.

    PubMed 18492024

  • 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.

    PubMed 16460491

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Albumin, Midodrine and Octreotide LAR in people with Ascites and Cirrhosis, run by US Department of Veterans Affairs at 1 site in United States.

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 3 inclusion and 10 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: finished, as of the sponsor's last update on 6 Mar 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 United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Recurrence of Ascites. (time frame: Variable depending on the patient, average 10 days). 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 NCT00108355, which also lists 10 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 6 Mar 2014.

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