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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
NEPH-ROSIS Trial 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.Check my eligibility
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.See study design
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.
NEPH-ROSIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Differences in mean arterial pressure.
Secondary outcome measures
Acute kidney injury reversal.
NEPH-ROSIS 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.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,507 Previous Clinical Trials
15,238,550 Total Patients Enrolled
7 Trials studying Liver Cirrhosis
4,916 Patients Enrolled for Liver Cirrhosis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants currently being admitted into this experiment?
"Contrary to current expectations, clinicaltrials.gov reveals that this study is not actively recruiting patients at the moment; it was posted on October 1st 2023 and last updated August 14th 2023. However, there are still over 1400 other medical trials searching for participants across the country."
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