Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGiuseppe Cullaro, MD

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Serum creatinine >4.0 mg/dL or current renal replacement therapy

Age >70 years

Unstable angina

Congestive heart failure requiring escalating medical therapy

Trial design

Treatments tested in this trial

  • Droxidopa capsules
  • Placebo

Treatment groups

75 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Giuseppe Cullaro, MD

Lead sponsor

Columbia University

Sponsor institution