Using albumin to help with fluid removal in patients with liver disease and swelling
Albumin Assisted Diuresis in Patients with Cirrhosis Decompensated by Ascites and Peripheral Edema, a Proof-of-concept Double Blind Randomized Trial
This study is testing whether giving albumin to people with liver disease and swelling can help them get rid of extra fluid better than just using regular saline.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Connecticut Healthcare System Federal |
| Locations | 1 site (West Haven, Connecticut) |
| Trial ID | NCT06812390 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are outpatient adults with decompensated cirrhosis, current or past ascites, and persistent lower extremity edema despite diuretic therapy.
Not a fit: Patients with severe kidney impairment, active infections, or recent significant changes in diuretic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve fluid management and kidney function in patients with cirrhosis and ascites.
How similar studies have performed: While this approach is being explored in a pilot setting, similar studies have shown promise in using albumin for fluid management in liver disease, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
West Haven, Connecticut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.