A Randomized, Double-Blind, Placebo-Controlled Trial of Droxidopa to Increase Mean Arterial Pressure in Hospitalized Acute Kidney Injury Associated with Decompensated Cirrhosis
DROP-AKI Trial: DROxidopa for mean arterial Pressure in decompensated cirrhosis Acute Kidney Injury
Sponsor: Unfunded
Enrolling: Male and Female Patients
IRB Number: AAAV7484
U.S. Govt. ID: NCT06937307
Contact: Transplant Clinical Research Center: (212) 305-3839 / tcrcstudyreferral@cumc.columbia.edu
Additional Study Information: The DROP-AKI Trial is studying whether droxidopa, an FDA-approved medication for low blood pressure, can help patients with liver cirrhosis who develop kidney problems during hospitalization. Although droxidopa is FDA-approved for certain types of low blood pressure, it is not approved to treat patients with cirrhosis of the liver who develop kidney injury. When patients with cirrhosis experience kidney injury, low blood pressure often contributes to the problem. This study will determine if droxidopa can safely raise blood pressure and potentially improve kidney function in these patients. Participants will receive either droxidopa or placebo for 28 days and will be monitored closely during hospitalization and after discharge. The study involves taking oral medication three times daily and regular blood pressure checks. Eligible participants must be at least 18 years old, have cirrhosis with signs of liver dysfunction, and have recently developed kidney problems with low blood pressure. This research could lead to new treatment options for a serious complication that currently has limited effective therapies. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
Investigator
Giuseppe Cullaro, MD
Do You Qualify?
Are you between the ages of 18 and 70 years old (inclusive)? Yes No
Are you currently hospitalized with cirrhosis (scarring of the liver)? Yes No
Have you recently developed kidney injury/dysfunction? Yes No
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For more information, please contact:
Transplant Clinical Research Center
tcrcstudyreferral@cumc.columbia.edu
(212) 305-3839