Actively Recruiting
Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury
Led by Giuseppe Cullaro, MD · Updated on 2025-06-04
75
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study tests whether a medication called droxidopa can help improve blood flow to the kidneys in people with liver cirrhosis who develop kidney problems while in the hospital. When someone with cirrhosis experiences kidney injury, having better blood pressure can help their kidneys recover. Droxidopa is an oral medication that may help raise blood pressure without requiring intensive care or invasive treatments. The study will compare droxidopa to a placebo (inactive pill) in 75 people hospitalized with cirrhosis and kidney injury. Participants will take either droxidopa or placebo pills for 28 days and be monitored for an additional 30 days. Researchers will measure changes in blood pressure and kidney function to determine if droxidopa is effective and safe for these patients. This research could identify a new treatment option for a serious complication of liver disease.
CONDITIONS
Official Title
Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed consent by subject or legally authorized representative
- Consent to blood and urine collection for biomarker analysis
- Ability to take oral medications
- At least 18 years of age
- Hospitalized at Columbia University Irving Medical Center
- Child-Pugh Score 65 B7 cirrhosis (documented by imaging, biopsy, or clinical evidence)
- KDIGO Stage 1 acute kidney injury or greater, defined as 650.3 mg/dL increase in serum creatinine within 48 hours or 6550% increase in serum creatinine from outpatient baseline
- Mean arterial pressure 65 85 mmHg averaged over 24 hours prior to randomization
- For women of childbearing potential: negative pregnancy test and agreement to use effective contraception
You will not qualify if you...
- Serum creatinine greater than 4.0 mg/dL or current renal replacement therapy
- Age greater than 70 years
- Severe cardiovascular disease including unstable angina, congestive heart failure requiring escalating medical therapy, symptomatic peripheral vascular disease, or any cardiovascular condition deemed severe by investigator
- Active gastrointestinal bleeding requiring at least 2 units of packed red blood cells during the screening period
- Acute respiratory failure requiring more than 6 liters of nasal cannula oxygen
- Use of medications that could interact with droxidopa including MAOI inhibitors, norepinephrine reuptake inhibitors, or other investigational drugs
- Pregnancy or breastfeeding
- Any episode of systolic blood pressure 180 mmHg or higher or diastolic blood pressure 120 mmHg or higher on two measurements, 1 minute apart
- Prior liver transplantation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
G
Giuseppe Cullaro, MD, MAS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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