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Loop Diuretic

Furosemide + Albumin for Liver Cirrhosis

Phase 4
Waitlist Available
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of cirrhosis
Presents with fluid retention as defined as ascites, edema, or pulmonary effusions requiring diuresis.
Must not have
Patients who are younger than 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is testing whether adding albumin to diuretics helps people with cirrhosis and fluid retention.

Who is the study for?
This trial is for adults over 18 with cirrhosis who are dealing with fluid retention, like swelling or fluid in the lungs. It's not for those under 18, pregnant women, or patients with a creatinine level above 2 mg/dL (a sign of kidney problems).
What is being tested?
The study tests if giving albumin (a blood protein) along with furosemide (a diuretic that helps get rid of excess water) works better than just furosemide alone in people with liver cirrhosis and fluid overload.
What are the potential side effects?
Possible side effects include dehydration, electrolyte imbalances from furosemide leading to muscle cramps or weakness, and allergic reactions or infections from the albumin infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with cirrhosis.
Select...
I am experiencing swelling or fluid build-up needing water pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am younger than 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amount of urine
Change in weight
Secondary study objectives
30-day readmission rates
Change in serum creatinine
Hospital length of stay
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Furosemide (Lasix) aloneActive Control1 Intervention
Cohort 1 will receive furosemide (Lasix) 40 to 80 mg IVP BID for at least 48 hours
Group II: Combination of furosemide (Lasix) and albuminActive Control2 Interventions
Cohort 2 will receive combination of furosemide (Lasix) 40 to 80 mg IVP BID and albumin (25%) 12.5 grams IV BID for at least 48 hours

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
439 Previous Clinical Trials
250,225 Total Patients Enrolled

Media Library

Furosemide Injection (Loop Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT04216784 — Phase 4
Liver Cirrhosis Research Study Groups: Furosemide (Lasix) alone, Combination of furosemide (Lasix) and albumin
Liver Cirrhosis Clinical Trial 2023: Furosemide Injection Highlights & Side Effects. Trial Name: NCT04216784 — Phase 4
Furosemide Injection (Loop Diuretic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04216784 — Phase 4
~3 spots leftby Dec 2025
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