NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients hospitalized with acute kidney injury. The main aims to answer are: • Does an algorithm that has low (\<80 mmHg) and high (≥80) MAP-targets lead to significant differences in mean arterial pressure? • Are there any serious adverse events (e.g., ischemia) in a high blood pressure algorithm as compared to a low blood pressure algorithm? • Are there any differences in the incidence of AKI reversal in the high v. low MAP-target groups? Participants will be: 1) Randomized to a clinical algorithm that will either target a low (\<80 mmHg) or high (≥80 mmHg) MAP. 2) Depending on their group, investigators will titrate commonly used medications to a specific MAP target. Researchers will compare the high and low MAP-target groups to see if these algorithms lead to significant changes in MAP, if they have any impact on AKI reversal, and if there are any adverse events in the high MAP-target group.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Hospitalized patients with decompensated cirrhosis, defined as a Child-Pugh Score ≥ 7

• Acute Kidney Injury: a ≥50% increase in sCr from an outpatient baseline sCr measured 7 to 365 days prior to admission

Locations
United States
California
University of California San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Giuseppe Cullaro, MD, MAS
giuseppe.cullaro@ucsf.edu
415 476 3143
Backup
Hannah Chao, BS
hannah.chao@ucsf.edu
415 476 3143
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2024-05-01
Participants
Target number of participants: 25
Treatments
Active_comparator: Low MAP-Target
This group will be randomized to a treatment algorithm that utilizes a low MAP-target (\<80 mmHg) to determine if titration of vasoconstrictors is needed.
Active_comparator: High MAP-Target
This group will be randomized to a treatment algorithm that utilizes a high MAP-target (≥80 mmHg) to determine if titration of vasoconstrictors is needed.
Sponsors
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov