Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

Albumin Assisted Diuresis in Patients with Cirrhosis Decompensated by Ascites and Peripheral Edema, a Proof-of-concept Double Blind Randomized 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.

Study Overview

• Status: Recruiting
• Conditions: Cirrhosis; Ascites Hepatic
• Intervention / Treatment: Drug: Albumin infusion (25% albumin); Drug: Normal Saline (0.9% NaCl)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Anahita Rabiee, MD, MHS; Phone Number: ext.1-5871 203-932-5711; Email: anahita.rabiee@va.gov
• Study Contact Backup: Name: Lynn F. Buchwalder, M.S.; Phone Number: ext.1-5871 203-932-5711; Email: Lynn.Buchwalder@va.gov

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • Recruiting
      • West Haven VA Medical Center
      • Contact: Anahita Rabiee, MD, MHS; Phone Number: ext.1-5871 203-932-5711; Email: anahita.rabiee@va.gov
      • Contact: Lynn F Buchwalder, M.S.; Phone Number: 203-932-5711; Email: Lynn.Buchwalder@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• 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 or eplerenone in place of spironolactone, and Bumex/Torsemide in place of furosemide are 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Albumin first; Albumin for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive placebo for one dose.	Drug: Albumin infusion (25% albumin); Albumin 25 gram infusion; Drug: Normal Saline (0.9% NaCl); 100 cc of normal saline
Placebo Comparator: Placebo first; Placebo for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive albumin for one dose.	Drug: Albumin infusion (25% albumin); Albumin 25 gram infusion; Drug: Normal Saline (0.9% NaCl); 100 cc of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fractional excretion of sodium (FENa)	Change in fractional excretion of sodium (FENa) with administration of albumin vs placebo	6 hours (baseline vs hour 6 after albumin vs placebo administration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in neuro hormonal markers	Changes in neuro hormonal markers including norepinephrine, renin, aldosterone	6 hours and 24 hours

Collaborators and Investigators

• Sponsor: Anahita Rabiee MD MHS
• Collaborators: Grifols Shared Services North America Inc

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 1, 2025
• First Submitted That Met QC Criteria: February 1, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: albumin; cirrhosis; ascites; diuresis
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis; Ascites
• Other Study ID Numbers: 1791319; 680800001061 (Other Grant/Funding Number: Grifols (Investigator initiated Sponsored Research))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No