Blood Pressure Target Algorithm for Acute Kidney Injury (NEPH-ROSIS Trial)

Phase 2 & 3

Recruiting

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how two different blood pressure target algorithms impact cirrhosis patients with acute kidney injury. Researchers will compare high and low MAP-target groups to see effects on MAP, AKI reversal, and adverse events.

Who is the study for?

This trial is for hospitalized cirrhosis patients with acute kidney injury, defined as a significant increase in serum creatinine from a baseline measured within the past year. They must have severe liver dysfunction (Child-Pugh Score ≥ 7). Those already on dialysis, lacking baseline creatinine measurements, needing high oxygen support, or with very high creatinine levels are excluded.

What is being tested?

The NEPH-ROSIS pilot trial is testing two blood pressure management strategies using medication to achieve either a low (<80 mmHg) or high (≥80 mmHg) mean arterial pressure target. The study will compare the effects on blood pressure control and reversal of acute kidney injury while monitoring for serious side effects like ischemia.

What are the potential side effects?

Potential side effects may include risks associated with maintaining different blood pressure targets such as ischemic events due to restricted blood flow at lower pressures or complications from higher pressures. Medication-related side effects will also be monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Differences in mean arterial pressure.

Secondary study objectives

Acute kidney injury reversal.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Low MAP-TargetActive Control1 Intervention

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 II: High MAP-TargetActive Control1 Intervention

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.

Do I qualify?Apply below to find out