RECRUITING

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

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Conditions

Acute Kidney InjuryCirrhosisDecompensated Cirrhosis of LiverDecompensated Cirrhosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-15
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06937307

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to provide informed consent by subject or legally authorized representative
  2. * Consent to blood and urine collection for biomarker analysis
  3. * Ability to take oral medications
  4. * At least 18 years of age
  5. * Hospitalized at Columbia University Irving Medical Center
  6. * Child-Pugh Score ≥ B7 cirrhosis (documented by imaging, biopsy, or clinical evidence)
  7. * KDIGO Stage 1 AKI or greater, defined as:
  8. * ≥0.3 mg/dL increase in serum creatinine within 48 hours OR
  9. * ≥50% increase in serum creatinine from outpatient baseline
  10. * Mean arterial pressure ≤85 mmHg averaged over 24 hours prior to randomization
  11. * For women of childbearing potential: negative pregnancy test and agreement to use effective contraception
  1. * Serum creatinine \>4.0 mg/dL or current renal replacement therapy
  2. * Age \>70 years
  3. * Severe cardiovascular disease, including:
  4. * Unstable angina
  5. * Congestive heart failure requiring escalating medical therapy
  6. * Symptomatic peripheral vascular disease
  7. * Any cardiovascular condition deemed severe by investigator
  8. * Active gastrointestinal bleeding, defined as requiring ≥ 2 units of packed red blood cells during the screening period
  9. * Acute respiratory failure requiring more than 6L of Nasal Canula
  10. * Use of medications that could interact with droxidopa including:
  11. * MAOI inhibitors
  12. * Norepinephrine reuptake inhibitors
  13. * Other investigational drugs
  14. * Pregnancy or breastfeeding
  15. * Any episode of a SBP ≥ 180 mmHg or a DBP ≥ 120 mmHg on two measurements, 1 minute apart
  16. * Prior liver transplantation

Contacts and Locations

Study Contact

Giuseppe Cullaro, MD, MAS
CONTACT
2123050914
gc2576@cumc.columbia.edu

Principal Investigator

Giuseppe Cullaro, MD, MAS
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Giuseppe Cullaro, MD

  • Giuseppe Cullaro, MD, MAS, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-15
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-05-15
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Acute Kidney Injury
  • Cirrhosis
  • Decompensated Cirrhosis

Additional Relevant MeSH Terms

  • Acute Kidney Injury
  • Cirrhosis
  • Decompensated Cirrhosis of Liver