Phase
Condition
Liver Disorders
Liver Disease
Scar Tissue
Treatment
Albumin infusion (25% albumin)
Normal Saline (0.9% NaCl)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Outpatient patients with decompensated cirrhosis with past or current ascites andpersistent lower extremity edema despite oral diuretic titration
Serum albumin of < 3.5 g/dL
Age >=18 years old
Exclusion
Exclusion Criteria:
Patients with GFR < 30mL/min/1.73 m2
Changes in oral diuretic regimen in the past 7 days (**patients can enter the studyafter 7 days of the change)
Large Volume paracentesis (LVP) in the past 7 days (**patients can enter the studyafter 7 days)
Albumin infusion within the previous 14 days (** patients can enter the study after 14 days)
Spontaneous Bacterial Peritonitis in the past month
Active variceal bleeding
Current Hepatic encephalopathy (>= Grade 2 based on West Haven criteria)
Co-administration of other diuretics such as Hydrochlorothiazide (amiloride oreplerenone in place of spironolactone, and Bumex/Torsemide in place of furosemideare acceptable)
Hypotension (Mean Arterial Pressure <65 mmHg, Systolic Blood pressure <90 mmHg)
Severe hyponatremia (Sodium <125 mEq/L)
previous diagnosis of overt heart failure (systolic EF < 50%)
Baseline oxygen requirement
Hypersensitivity to albumin preparations
Study Design
Connect with a study center
West Haven VA Medical Center
West Haven, Connecticut 06516
United StatesActive - Recruiting
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