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

Acute Kidney Injury Clinical Trial

— NEPH-ROSIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06000748
• Other study ID #: 23-39806
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 1, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: Giuseppe Cullaro, MD, MAS
• Phone: 415 476 3143
• Email: giuseppe.cullaro[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cirrhosis
• Fibrosis
• Hepatorenal Syndrome
• Hypertension, Portal
• Kidney Tubular Necrosis, Acute
• Liver Cirrhosis
• Necrosis
• Portal Hypertension
• Wounds and Injuries

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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