A Phase 2 interventional study of Albumin infusion (25% albumin) and Normal Saline (0.9% NaCl) in Cirrhosis and Ascites Hepatic, sponsored by Anahita Rabiee MD MHS. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Anahita Rabiee MD MHS · Phase 2, Interventional, and Other
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.
247 studies on the registry are indexed under Ascites; 57 are open to participants now.
This study's planned enrollment of 20 is below the median of 54 across 179 interventional studies indexed under Ascites.
Browse Ascites studies →This is the only study on the registry with Anahita Rabiee MD MHS as lead sponsor.
Compared within Ascites, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fibrosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive albumin for one dose.
Drug: Albumin infusion (25% albumin) · Drug: Normal Saline (0.9% NaCl)
Albumin 25 gram infusion
100 cc of normal saline
Change in fractional excretion of sodium (FENa)
Change in fractional excretion of sodium (FENa) with administration of albumin vs placebo
Time frame: 6 hours (baseline vs hour 6 after albumin vs placebo administration)
Changes in neuro hormonal markers
Changes in neuro hormonal markers including norepinephrine, renin, aldosterone
Time frame: 6 hours and 24 hours
Plan to share: No
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