Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites (NCT06812390) | Clinical Trial Compass
RecruitingPhase 2
Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites
United States20 participantsStarted 2025-02-28
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in fractional excretion of sodium (FENa)
Timeframe: 6 hours (baseline vs hour 6 after albumin vs placebo administration)