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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: MAP-Target Algorithm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single-blind, randomized control, parallel-group, pragmatic trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low MAP-Target<br>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. | Drug: MAP-Target Algorithm<br>* 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.<br>|
| Active Comparator: High MAP-Target<br>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. | Drug: MAP-Target Algorithm<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRAGMATIC, FEASIBILITY