Phase 4
N=29
Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis
Ascites · Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT00108355 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Time to Recurrence of Ascites. — 10; 8 days — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Albumin (Drug); Intravenous Saline Infusion (Albumin placebo) (Drug); Midodrine (Drug); Oral tablet (Midodrine placebo) (Drug); Octreotide LAR (Drug); Saline injection (Octreotide LAR placebo) (Drug); Large Volume Paracentesis (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Recurrence of Ascites. |
10; 8 | <0.05 sig |
| SECONDARY Development of Post-paracentesis Circulatory Dysfunction (PCD) |
2; 2 | — |
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.
Eligibility 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)
- Serum creatinine > 3 mg/dl
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00108355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.