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

Description

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

Acute Kidney Injury, Cirrhosis, Decompensated Cirrhosis of Liver

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Acute Kidney Injury
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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 ≥ B7 cirrhosis (documented by imaging, biopsy, or clinical evidence)
  • * KDIGO Stage 1 AKI or greater, defined as:
  • * ≥0.3 mg/dL increase in serum creatinine within 48 hours OR
  • * ≥50% increase in serum creatinine from outpatient baseline
  • * Mean arterial pressure ≤85 mmHg averaged over 24 hours prior to randomization
  • * For women of childbearing potential: negative pregnancy test and agreement to use effective contraception
  • * Serum creatinine \>4.0 mg/dL or current renal replacement therapy
  • * Age \>70 years
  • * Severe cardiovascular disease, including:
  • * Unstable angina
  • * Congestive heart failure requiring escalating medical therapy
  • * Symptomatic peripheral vascular disease
  • * Any cardiovascular condition deemed severe by investigator
  • * Active gastrointestinal bleeding, defined as requiring ≥ 2 units of packed red blood cells during the screening period
  • * Acute respiratory failure requiring more than 6L of Nasal Canula
  • * Use of medications that could interact with droxidopa including:
  • * MAOI inhibitors
  • * Norepinephrine reuptake inhibitors
  • * Other investigational drugs
  • * Pregnancy or breastfeeding
  • * Any episode of a SBP ≥ 180 mmHg or a DBP ≥ 120 mmHg on two measurements, 1 minute apart
  • * Prior liver transplantation

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Giuseppe Cullaro, MD,

Giuseppe Cullaro, MD, MAS, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

2027-12-31