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Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

NCT06812390 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-11

No results posted yet for this study

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.

Conditions

  • Cirrhosis
  • Ascites Hepatic

Interventions

DRUG

Albumin infusion (25% albumin)

Albumin 25 gram infusion

DRUG

Normal Saline (0.9% NaCl)

100 cc of normal saline

Sponsors & Collaborators

  • Grifols Shared Services North America Inc

    collaborator UNKNOWN

  • Anahita Rabiee MD MHS

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2026-12-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06812390 on ClinicalTrials.gov