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NCT04434209 · ClinicalTrials.gov registry record · NA
A Study Looking at the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients With Sepsis (Limiting AKI Progression In Sepsis)
A NA study, sponsored by BioMérieux.
- Terminated
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT04434209: Clinical Trial NA study, sponsored by BioMérieux.
NCT04434209 is a NA study that was terminated before completion, run by BioMérieux. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04434209, a NA study, was terminated before completion, sponsored by BioMérieux.
- TERMINATED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI. Two urinary biomarkers have been identified as early indicators of AKI. The NephroCheck® test is a commercially available test that uses these biomarkers, and this study assesses the use of these in reducing negative clinical outcomes for patients with sepsis-associated AKI. The study will enroll subjects diagnosed with sepsis, including septic shock, who will be randomly assigned to either receive NephroCheck®-guided kidney-sparing and fast-tracking interventions; or to receive current Standard of Care assessment and treatment. NOTE: Participants are no longer being recruited to this study.
Primary Outcome
Measured by composite number of deaths, dialysis or progression of AKI. Dialysis defined as any form of renal replacement therapy (RRT); progression of AKI defined as Stage 0 to 2/3 or Stage 1 to 3.
Interventions
- OTHER Standard of Care
- DEVICE Subject management guided by NephroCheck® test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-01-19 |
| Est. Completion | 2022-02-14 |
| Phase | NA |
Why NCT04434209 stopped before completion
NCT04434209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT04434209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04434209 about?
NCT04434209 is a clinical study titled "A Study Looking at the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients With Sepsis (Limiting AKI Progression In Sepsis)". Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI. Two urinary biomarkers have been identified as early indicators of AKI. The NephroCheck® tes...
What is the current status of trial NCT04434209?
This trial is currently terminated. It is a NA study. The enrollment target is 19 participants. The study started on 2021-01-19. Estimated completion is 2022-02-14.
What interventions are being tested in trial NCT04434209?
The interventions under investigation include: Standard of Care (OTHER), Subject management guided by NephroCheck® test (DEVICE).
Who is sponsoring clinical trial NCT04434209?
This trial is sponsored by BioMérieux, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04434209's enrollment target sits among peer trials
19 1861st of 2000 higher than 138 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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