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

Phase 2

Terminated

• Conditions: Hepatorenal Syndrome; Prerenal Failure; Portal Hypertension; Acute Kidney Injury; Acute Tubule Necrosis; Cirrhosis
• Interventions: Drug: MAP-Target Algorithm

• Registration Number: NCT06000748
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-21
• Study Start: 2024-02-01
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High MAP-Target	MAP-Target Algorithm	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.
Low MAP-Target	MAP-Target Algorithm	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.

Primary Outcome Measures

Name	Time	Method
Differences in mean arterial pressure.	14 days.	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.

Secondary Outcome Measures

Name	Time	Method
Acute kidney injury reversal.	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.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States