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

NCT ID: NCT06000748

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-07-31

Brief 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.

Conditions

Acute Kidney Injury; Cirrhosis; Portal Hypertension; Hepatorenal Syndrome; Acute Tubule Necrosis; Prerenal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

MAP-Target Algorithm

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

MAP-Target Algorithm

Intervention Type: 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.

Interventions

MAP-Target Algorithm

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Cullaro, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

23-39806

Identifier Type: -

Identifier Source: org_study_id