Cirrhosis, LiverPhase 4NCT04216784
Compare the Diuretic Effect With Furosemide vs Furosemide and Albumin Combined in Cirrhotic Patients
A Phase 4 study testing Furosemide Injection and Albumin Human in people with Cirrhosis, Liver and Volume Overload, run by Rush University Medical Center at 1 site in United States.
Trial summary
A common complication of the progression of cirrhosis is fluid retention (ascites, edema, or pleural effusion). Loop diuretics are the treatment of choice for fluid retention in cirrhotic patients; however, many of these patients demonstrate diuretic resistance, requiring higher doses of the diuretics to achieve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Volume Overload, Fluid Overload
- What is being tested?
- Furosemide Injection and Albumin Human
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 1 Apr 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age >18 years old)
- Diagnosis of cirrhosis
- Presents with fluid retention as defined as ascites, edema, or pulmonary effusions requiring diuresis.
Who cannot join
- Patients who are younger than 18 years of age
- Patients who are currently pregnant
- Patients who present with a serum creatinine greater than 2 mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Comparison of Diuretic Effect With Furosemide Alone Versus the Combination of Furosemide and Albumin in Cirrhotic Patients
A common complication of the progression of cirrhosis is fluid retention (ascites, edema, or pleural effusion). Loop diuretics are the treatment of choice for fluid retention in cirrhotic patients; however, many of these patients demonstrate diuretic resistance, requiring higher doses of the diuretics to achieve adequate diuresis. The cause of this diuretic resistance is hypothesized to be secondary to hypoalbuminemia which has led some providers to give human albumin in combination with loop diuretics to increase intravascular volume and facilitate diuresis. However, this practice remains controversial because minimal data exists to support its efficacy. The purpose of this study is to compare the efficacy of diuretics alone versus diuretics in combination with albumin in cirrhotic patients presenting with fluid retention.
Read the detailed description
The purpose of this single center, prospective study is to compare the efficacy of two strategies for diuresis in patients with cirrhosis, the use of furosemide (Lasix®) alone versus the combination of furosemide (Lasix ®) and albumin (25%). The investigators will perform a single-center, prospective study with data collected as result of standard of care at Rush University Medical Center (RUMC). Patients who are 18 years of age and older, have diagnosed cirrhosis, and present to RUMC with fluid retention will be identified by the Hepatology and/or Surgery attending and be screened for inclusion in the study. Each patient will be randomized into one of the two cohorts and will have 50% chance of being placed into either cohort. Cohort 1 will receive furosemide (Lasix) 40 to 80 mg intravenous push (IVP) twice a day (BID) for at least 48 hours and cohort 2 will receive combination of furosemide (Lasix) 40 to 80 mg IVP BID and albumin (25%) 12.5 grams BID for at least 48 hours.
- Conditions
- Cirrhosis, Liver, Volume Overload, Fluid Overload
- Being tested
- Furosemide Injection, Albumin Human
- Medical subject headings
- Liver Cirrhosis, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide InjectionDrug
Patient will receive furosemide intravenously
Albumin HumanDrug
Patient will receive albumin (25%) 12.5 gm intravenously
| Study group | Role | What they receive |
|---|---|---|
| Furosemide (Lasix) alone | Active comparator | Cohort 1 will receive furosemide (Lasix) 40 to 80 mg IVP BID for at least 48 hours Receives: Drug: Furosemide Injection |
| Combination of furosemide (Lasix) and albumin | Active comparator | 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 Receives: Drug: Furosemide Injection; Drug: Albumin Human |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Change in weight defined as weight loss of 1 kilogram
Measured: 2-7 days
Amount of Urine
The amount of urine produced over 24 hours.
Measured: 2-7 days
Secondary outcomes (4)
Change in Serum Creatinine
Changes in renal function were observed in patients from the two study arms
. Study was terminated early due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. At no point before the study was halted was data collected on patients enrolled into the study, nor is data going to be collected in patients that were enrolled into the study.
Measured: Through completion of study, up to an average of 1 year
Hospital Length of Stay
duration of hospital admission
Data was not collected for this study. Study was terminated early due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. Ultimately this dispute resulted in study termination. At no point before the study was halted was data collected on patients enrolled into the study, nor is data going to be collected in patients that were enrolled into the study.
Measured: Through completion of study, up to an average of 1 year
30-day Readmission Rates
Number of occurrences that the patient is readmitted after discharge within 30 days
Data was not collected for this study. Study was terminated early due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. Ultimately this dispute resulted in study termination. At no point before the study was halted was data collected on patients enrolled into the study, nor is data going to be collected in patients that were enrolled into the study.
Measured: 30 days from discharge
Patient Survival
Patient survival rates to be closely monitored in patients from the two study arms
Data was not collected for this study. Study was terminated early due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. Ultimately this dispute resulted in study termination. At no point before the study was halted was data collected on patients enrolled into the study, nor is data going to be collected in patients that were enrolled into the study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start19 Dec 2019
- Primary completion30 Dec 2023
- Study completion1 Apr 2024
Why it stopped: The study halted prematurely due to staffing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lance Lance Lineberger, PharmD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216784
- Sponsor's protocol ID
- 19092507-IRB01
- Status last verified
- Aug 2025
- First submitted
- 23 Dec 2019
- Last updated
- 16 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diuretic Effect With Furosemide Alone Versus the Combination of Furosemide and Albumin in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT04216784
- Acronym / sponsor ID
- 19092507-IRB01
- Conditions
- Cirrhosis, Liver, Volume Overload, Fluid Overload
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study halted prematurely due to staffing.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Posted 9 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A common complication of the progression of cirrhosis is fluid retention (ascites, edema, or pleural effusion). Loop diuretics are the treatment of choice for fluid retention in cirrhotic patients; however, many of these patients demonstrate diuretic resistance, requiring higher doses of the diuretics to achieve adequate diuresis. The cause of this diuretic resistance is hypothesized to be secondary to hypoalbuminemia which has led some providers to give human albumin in combination with loop diuretics to increase intravascular volume and facilitate diuresis. However, this practice remains controversial because minimal data exists to support its efficacy. The purpose of this study is to compare the efficacy of diuretics alone versus diuretics in combination with albumin in cirrhotic patients presenting with fluid retention.
Detailed description
The purpose of this single center, prospective study is to compare the efficacy of two strategies for diuresis in patients with cirrhosis, the use of furosemide (Lasix®) alone versus the combination of furosemide (Lasix ®) and albumin (25%). The investigators will perform a single-center, prospective study with data collected as result of standard of care at Rush University Medical Center (RUMC). Patients who are 18 years of age and older, have diagnosed cirrhosis, and present to RUMC with fluid retention will be identified by the Hepatology and/or Surgery attending and be screened for inclusion in the study. Each patient will be randomized into one of the two cohorts and will have 50% chance of being placed into either cohort. Cohort 1 will receive furosemide (Lasix) 40 to 80 mg intravenous push (IVP) twice a day (BID) for at least 48 hours and cohort 2 will receive combination of furosemide (Lasix) 40 to 80 mg IVP BID and albumin (25%) 12.5 grams BID for at least 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furosemide (Lasix) alone | Active comparator | Drug: Furosemide InjectionCohort 1 will receive furosemide (Lasix) 40 to 80 mg IVP BID for at least 48 hours |
| Combination of furosemide (Lasix) and albumin | Active comparator | Drug: Furosemide Injection, Drug: Albumin HumanCohort 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age >18 years old)
- Diagnosis of cirrhosis
- Presents with fluid retention as defined as ascites, edema, or pulmonary effusions requiring diuresis.
Key exclusion criteria (3 listed)
- Patients who are younger than 18 years of age
- Patients who are currently pregnant
- Patients who present with a serum creatinine greater than 2 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide InjectionPatient will receive furosemide intravenously | Drug | Combination of furosemide (Lasix) and albumin, Furosemide (Lasix) alone |
| Albumin HumanPatient will receive albumin (25%) 12.5 gm intravenously | Drug | Combination of furosemide (Lasix) and albumin |
Primary outcome
Change in Weight
Time frame: 2-7 days
Change in weight defined as weight loss of 1 kilogram
Amount of Urine
Time frame: 2-7 days
The amount of urine produced over 24 hours.
4 secondary outcomes
Change in Serum Creatinine
Time frame: Through completion of study, up to an average of 1 year
Hospital Length of Stay
Time frame: Through completion of study, up to an average of 1 year
30-day Readmission Rates
Time frame: 30 days from discharge
Patient Survival
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lance Lance Lineberger, PharmD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Furosemide Injection and Albumin Human in people with Cirrhosis, Liver and Volume Overload, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: 2-7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.