Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Cirrhosis, Ascites Hepatic

In brief

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.

Key facts

Study ID

NCT06812390

Run by

Anahita Rabiee MD MHS

People needed

20

Starts

2025-02-28

Expected to finish

2027-03-01

Last updated by the study team

2025-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• West Haven VA Medical Center — West Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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