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โ† Trials
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Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

RecruitingPhase 2Ages 18 Years - anyAllAnahita Rabiee MD MHS
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Albumin infusion (25% albumin)
  • Normal Saline (0.9% NaCl)
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Where

1 site
West Haven VA Medical Center
West Haven, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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