Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnahita Rabiee MD MHS
About this trial
A small, pilot proof-of-concept placebo-controlled trial to explore the effects of albumin on diuresis in patients with cirrhosis, ascites and lower extremity edema. We will additionally investigate albumin's effect on preventing neurohumoral activation, and acute kidney injury after diuresis.
Eligibility criteria
Qualifiers
Outpatient patients with decompensated cirrhosis with past or current ascites and persistent lower extremity edema despite oral diuretic titration
Serum albumin of < 3.5 g/dL
Age >=18 years old
Disqualifiers
Patients with GFR < 30mL/min/1.73 m2
Changes in oral diuretic regimen in the past 7 days (**patients can enter the study after 7 days of the change)
Large Volume paracentesis (LVP) in the past 7 days (**patients can enter the study after 7 days)
Albumin infusion within the previous 14 days (** patients can enter the study after 14 days)
Trial design
Treatments tested in this trial
- Albumin infusion (25% albumin)
- Normal Saline (0.9% NaCl)
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Anahita Rabiee MD MHS
Lead sponsor
VA Connecticut Healthcare System
Sponsor institution
Grifols Shared Services North America, Inc.
Collaborator
Source ClinicalTrials.gov