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

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ClinicalTrials.gov Identifier: NCT00108355
Recruitment Status : Completed
First Posted : April 15, 2005
Results First Posted : March 6, 2014
Last Update Posted : March 6, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information
First Submitted Date  ICMJE April 14, 2005
First Posted Date  ICMJE April 15, 2005
Results First Submitted Date  ICMJE December 11, 2013
Results First Posted Date  ICMJE March 6, 2014
Last Update Posted Date March 6, 2014
Study Start Date  ICMJE December 2003
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2014)
Time to Recurrence of Ascites. [ Time Frame: Variable depending on the patient, average 10 days ]
Comparison between Albumin (Control group) and Vasoconstrictor (Treatment group)
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00108355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2014)
Development of Post-paracentesis Circulatory Dysfunction (PCD) [ Time Frame: 6 days after paracentesis ]
Defined as an increase in Plasma Renin Activity (PRA) by >50% from baseline to a level > 4 ng/mL/h at post-paracentesis day
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis
Official Title  ICMJE Vasoconstrictors as Alternatives to Albumin After Large Volume Paracentesis in Cirrhosis
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ascites
  • Cirrhosis
Intervention  ICMJE
  • Drug: Albumin
    Intravenous Albumin at a dose of 8g/liter of ascitic fluid removed
  • Drug: Intravenous Saline Infusion (Albumin placebo)
    Intravenous saline Infusion (Albumin placebo)
  • Drug: Midodrine
    Midodrine oral tablet at 10 mg three times a day.
  • Drug: Oral tablet (Midodrine placebo)
    Oral tablet (Midodrine placebo) three times a day
  • Drug: Octreotide LAR
    Octreotide LAR 20 mg intramuscular injection every 30 days
  • Drug: Saline injection (Octreotide LAR placebo)
    Saline intramuscular injection 5 cc every 30 days.
  • Procedure: Large Volume Paracentesis
    Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.
    Other Name: LVP
Study Arms  ICMJE
  • 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)

    Interventions:
    • Drug: Albumin
    • Drug: Oral tablet (Midodrine placebo)
    • Drug: Saline injection (Octreotide LAR placebo)
    • Procedure: Large Volume Paracentesis
  • 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

    Interventions:
    • Drug: Intravenous Saline Infusion (Albumin placebo)
    • Drug: Midodrine
    • Drug: Octreotide LAR
    • Procedure: Large Volume Paracentesis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2014)
29
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00108355
Other Study ID Numbers  ICMJE CLIN-016-03F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guadalupe Garcia-Tsao, MD VA Connecticut Health Care System (West Haven)
PRS Account VA Office of Research and Development
Verification Date February 2014

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