Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around

Description

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.

Keywords

Acute Kidney Injury, Cirrhosis, Portal Hypertension, Hepatorenal Syndrome, Acute Tubule Necrosis, Prerenal Failure, PRAGMATIC, FEASIBILITY, Liver Cirrhosis, Acute Kidney Tubular Necrosis, Fibrosis, Necrosis, Wounds and Injuries, Low MAP-Target, High MAP-Target

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  1. Patients without a baseline (7 - 365 days prior to AKI development) sCr measurement;
  2. Patients who are already on kidney replacement therapy (KRT) at the time of enrollment;
  3. Patients with an oxygen requirement greater than 6L via nasal cannula;
  4. Patients with a serum creatinine level exceeding 5 mg/dL.

Location

  • UCSF
    San Francisco California 94143 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06000748
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 25 study participants
Last Updated