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


Description

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

Trial Eligibility

Inclusion Criteria: * 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 Exclusion Criteria: 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.

Study Info

Organization

University of California, San Francisco


Primary Outcome

Differences in mean arterial pressure.


Outcome Timeframe 14 days.

NCTID NCT06000748

Phases PHASE2,PHASE3

Primary Purpose TREATMENT

Start Date 2024-02-01

Completion Date 2024-05-01

Enrollment Target 25

Interventions

DRUG MAP-Target Algorithm

Locations Recruiting

University of California San Francisco

United States, California, San Francisco


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