BridgeMD
New treatment option for Cirrhosis
Official title Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites
ClinicalTrials.gov ID: NCT06812390
What this study is testing
What is Albumin infusion (25% albumin)?
Albumin infusion (25% albumin) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cirrhosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full 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
The study team makes the final eligibility decision.
Where it's taking place
- West Haven, Connecticut, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.