RecruitingPhase 2NCT06812390

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

Sponsor

Anahita Rabiee MD MHS

Enrollment

20 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

Cirrhosis Ascites Hepatic

Summary

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria13

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