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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT00108355 (opens ClinicalTrials.gov in a new tab)Other idCLIN-016-03F
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
29 participants (actual)
Sponsor
US Department of Veterans Affairs · Fed
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Dec 2003
Primary completion
Aug 2010
Completion
Aug 2012
First posted
15 Apr 2005 (estimated)
Last update posted
6 Mar 2014 (estimated)
Conditions
Ascites · Cirrhosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042006200820102012
  1. Ph 4

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

    NCT00108355

    Dec 2003 to Aug 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • AlbuminDrug
  • Intravenous Saline Infusion (Albumin placebo)Drug
  • MidodrineDrug
  • Oral tablet (Midodrine placebo)Drug
  • Octreotide LARDrug
  • Saline injection (Octreotide LAR placebo)Drug
  • Large Volume ParacentesisProcedure

Arms2

  • Active comparator

    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)

  • Experimental

    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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to Recurrence of Ascites.

    Time frame · Variable depending on the patient, average 10 days

    Registry description

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

Secondary outcomes(1)

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

    Time frame · 6 days after paracentesis

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Variable depending on the patient, average 10 days

Time to Recurrence of Ascites.

GroupValue (days)
Albumin (Control Group)10
Vasoconstrictor (Treatment Group)8
Secondary and other outcome results(1)
Secondary outcomeNumber· 6 days after paracentesis

Development of Post-paracentesis Circulatory Dysfunction (PCD)

GroupValue (participants)
Albumin (Control Group)2
Vasoconstrictor (Treatment Group)2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
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)–0 / 133 / 13
Vasoconstrictor (Treatment 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–0 / 124 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

More studies

3 studies on this page

Indexing hint: Randomized controlled trial · 2012

The combination of octreotide and midodrine is not superior to albumin in preventing recurrence of ascites after large-volume paracentesis.

Bari et al. 2012Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Associationcited by 22

PMID 22801062PMC3678262DOI 10.1016/j.cgh.2012.06.027PUB-22801062

Rights unknown
Source link

PubMed tag: none · 2009

The effect of 1 month of therapy with midodrine, octreotide-LAR and albumin in refractory ascites: a pilot study.

Tandon et al. 2009Liver international : official journal of the International Association for the Study of the Livercited by 34

PMID 18492024DOI 10.1111/j.1478-3231.2008.01778.xPUB-18492024

Full text at the publisher
Publisher page

Indexing hint: Clinical trial · 1999

Reversal of type 1 hepatorenal syndrome with the administration of midodrine and octreotide.

Angeli et al. 1999Hepatology (Baltimore, Md.)cited by 320

PMID 10347109DOI 10.1002/hep.510290629PUB-10347109

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultBernardi 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. PMID 22095893
  • ResultMoreau 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. PMID 11772973
  • ResultLata 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. PMID 18251131
  • ResultAppenrodt 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. PMID 18410283
  • ResultSingh 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. PMID 18547224
  • ResultSingh 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. PMID 16460491

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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