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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Albumin infusion (25% albumin)
DrugAlbumin 25 gram infusion
Normal Saline (0.9% NaCl)
Drug100 cc of normal saline
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Albumin firstActive comparator 0 interventions
Group B: Placebo firstPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in fractional excretion of sodium (FENa)
Change in fractional excretion of sodium (FENa) with administration of albumin vs placebo
Time frame
6 hours (baseline vs hour 6 after albumin vs placebo administration)Secondary outcomes
1
Changes in neuro hormonal markers
Changes in neuro hormonal markers including norepinephrine, renin, aldosterone
Time frame
6 hours and 24 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Anahita Rabiee MD MHS
Lead sponsor
VA Connecticut Healthcare System
Sponsor institution
Grifols Shared Services North America, Inc.
Collaborator
Source ClinicalTrials.gov