RECRUITING

Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

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Conditions

CirrhosisAscites Hepaticalbuminascitesdiuresis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-28
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06812390

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Outpatient patients with decompensated cirrhosis with past or current ascites and persistent lower extremity edema despite oral diuretic titration
  2. * Serum albumin of \< 3.5 g/dL
  3. * Age \>=18 years old
  1. * Patients with GFR \< 30mL/min/1.73 m2
  2. * Changes in oral diuretic regimen in the past 7 days (\*\*patients can enter the study after 7 days of the change)
  3. * Large Volume paracentesis (LVP) in the past 7 days (\*\*patients can enter the study after 7 days)
  4. * Albumin infusion within the previous 14 days (\*\* patients can enter the study after 14 days)
  5. * Spontaneous Bacterial Peritonitis in the past month
  6. * Active variceal bleeding
  7. * Current Hepatic encephalopathy (\>= Grade 2 based on West Haven criteria)
  8. * Co-administration of other diuretics such as Hydrochlorothiazide (amiloride or eplerenone in place of spironolactone, and Bumex/Torsemide in place of furosemide are acceptable)
  9. * Hypotension (Mean Arterial Pressure \<65 mmHg, Systolic Blood pressure \<90 mmHg)
  10. * Severe hyponatremia (Sodium \<125 mEq/L)
  11. * previous diagnosis of overt heart failure (systolic EF \< 50%)
  12. * Baseline oxygen requirement
  13. * Hypersensitivity to albumin preparations

Contacts and Locations

Study Contact

Anahita Rabiee, MD, MHS
CONTACT
203-932-5711
anahita.rabiee@va.gov
Lynn F. Buchwalder, M.S.
CONTACT
203-932-5711
Lynn.Buchwalder@va.gov

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Anahita Rabiee MD MHS

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-28
Study Completion Date2027-03

Study Record Updates

Study Start Date2025-02-28
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • albumin
  • cirrhosis
  • ascites
  • diuresis

Additional Relevant MeSH Terms

  • Cirrhosis
  • Ascites Hepatic