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

Phase 3TerminatedNCT06000748

University of California, San Francisco6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acute Kidney Injury Cirrhosis Portal Hypertension

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Differences in mean arterial pressure.

The investigators will determine if a high, as compared to a low, MAP-target algorithm leads to significantly different changes in MAP. This will be completed by comparing the change in MAP from the baseline to the completion of the study.

Time frame: 14 days.

Secondary Outcomes

Acute kidney injury reversal.

The investigators will determine if a high, as compared to a low, MAP-target algorithm leads to significantly different incidences of acute kidney injury reversal. This will be defined as a decrease in serum creatinine (sCr) to within 0.3 mg/dL of the baseline sCr.

Time frame: 14 days