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NCT Number: NCT06812390

Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

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.

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Key information

Conditions

Cirrhosis Ascites Ascites Hepatic Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albumin infusion (25% albumin)

Drug

Albumin 25 gram infusion

Normal Saline (0.9% NaCl)

Drug

100 cc of normal saline

Primary outcomes

  1. Change in fractional excretion of sodium (FENa)

    Time frame: 6 hours (baseline vs hour 6 after albumin vs placebo administration)

    Change in fractional excretion of sodium (FENa) with administration of albumin vs placebo

Secondary outcomes

  1. Changes in neuro hormonal markers

    Time frame: 6 hours and 24 hours

    Changes in neuro hormonal markers including norepinephrine, renin, aldosterone

Study contacts

Contact information is provided by the study sponsor or research team.

Anahita Rabiee, MD, MHS

CONTACT

[email protected]

203-932-5711 ext. ext.1-5871

Lynn F. Buchwalder, M.S.

CONTACT

[email protected]

203-932-5711 ext. ext.1-5871

Sponsors and collaborators

Lead sponsor

Anahita Rabiee MD MHS

Fed

Collaborators

  • Grifols Shared Services North America, Inc.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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