Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

Anahita Rabiee MD MHS

Status and phase: Enrolling; Phase 2

Conditions: Cirrhosis; Ascites Hepatic

Treatments: Drug: Albumin infusion (25% albumin); Drug: Normal Saline (0.9% NaCl)

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT06812390

1791319

680800001061 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Albumin first

Active Comparator group

Description:

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.

Placebo first

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal Saline (0.9% NaCl)

Drug: Albumin infusion (25% albumin)