Using albumin to help with fluid removal in patients with liver disease and swelling

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial investigates the effects of albumin infusion on diuresis in patients suffering from cirrhosis and ascites, particularly those with persistent lower extremity edema despite oral diuretic treatment. The study is placebo-controlled and aims to assess not only the efficacy of albumin in promoting fluid removal but also its potential role in preventing neurohumoral activation and acute kidney injury following diuresis. Participants will receive either a 25% albumin infusion or normal saline as part of the intervention.

Why it matters

Who can join: the full rules

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

Where it's running

• West Haven VA Medical Center
  West Haven, Connecticut, United States Recruiting

Study contacts

• Study coordinator: Anahita Rabiee, MD, MHS
• Email: anahita.rabiee@va.gov
• Phone: 203-932-5711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.