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Terminated

NCT Number: NCT06000748

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

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.

Why the study stopped: Investigator Left Institution
Terminated

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Key information

Conditions

Acute Kidney Injury Acute Tubule Necrosis Cirrhosis Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Hepatorenal Syndrome Hypertension, Portal Kidney Cortex Necrosis Kidney Diseases Liver Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension Prerenal Failure Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

MAP-Target Algorithm

Drug

This is a clinical treatment algorithm that will determine the escalation and deescalation of vasoconstrictor utilization based on a target MAP, either high (≥80 mmHg) in the treatment group and low (< 80 mmHg) in the comparator group.

Primary outcomes

  1. Differences in Mean Arterial Pressure.

    Time frame: Baseline and End of Study or Day 14.

Secondary outcomes

  1. Acute Kidney Injury Reversal, Which Was Defined as a Decrease in sCr to Within 0.3 mg/dL of Baseline.

    Time frame: 14 days

    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.

Interested in participating?

Terminated

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Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: NEPH-ROSIS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2023
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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