Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

Description

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.

Conditions

Cirrhosis, Ascites Hepatic

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Study Overview

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Study Details

Study overview

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.

Albumin Assisted Diuresis in Patients with Cirrhosis Decompensated by Ascites and Peripheral Edema, a Proof-of-concept Double Blind Randomized Trial

Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

Condition
Cirrhosis
Intervention / Treatment

-

Contacts and Locations

West Haven

West Haven VA Medical Center, West Haven, Connecticut, United States, 06516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Anahita Rabiee MD MHS,

Study Record Dates

2027-03