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NCT05094154 · ClinicalTrials.gov registry record · Phase 4
Effect of Antibiotic Choice On ReNal Outcomes (ACORN)
A Phase 4 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 2,634
- Enrollment target
NCT05094154: Completed Phase 4 study, sponsored by Vanderbilt University Medical Center.
NCT05094154 is a Phase 4 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 2,634 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (408% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05094154, a Phase 4 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 2,634 participants
- Enrollment target
Study Summary
Sepsis is one of the most common causes of acute illness and death in the United States. Early, empiric broad-spectrum antibiotics are a mainstay of sepsis treatment. Two classes of antibiotics with activity against Pseudomonas, anti-pseudomonal cephalosporins and anti-pseudomonal penicillins, are commonly used for acutely ill adults with sepsis in current practice. Recent observational studies, however, have raised concern that anti-pseudomonal penicillins may cause renal toxicity. Anti-pseudomonal cephalosporins, by comparison, may be associated with a risk of neurotoxicity. Rigorous, prospective data regarding the comparative effectiveness and toxicity of these two classes of medications among acutely ill patients are lacking. The investigator propose a randomized trial comparing the impact of anti-pseudomonal cephalosporins and anti-pseudomonal penicillins on renal outcomes of acutely ill patients.
Primary Outcome
Acute Kidney Injury Score between randomization and day 14. The acute kidney injury score is an ordinal outcome containing the stages of AKI as defined by Kidney Disease: Improving Global Outcomes (KDIGO) creatinine criteria, new renal replacement therapy (RRT), and death: 0 = No AKI 1. = Stage 1 AKI (Creatinine increase by 1.5-1.9 times baseline OR increase by \>= 0.3 mg/dL) 2. = Stage 2 AKI (Creatinine increase by 2.0-2.9 times baseline) 3. = Stage 3 AKI (Creatinine increase by \>= 3.0 times
Interventions
- DRUG anti-pseudomonal cephalosporin
- DRUG anti-pseudomonal penicillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,634 participants |
| Start Date | 2021-11-10 |
| Est. Completion | 2022-10-21 |
| Phase | Phase 4 |
What the finished NCT05094154 record still lists
NCT05094154 is an interventional study that assigns participants to a tested intervention. Its 2,634 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (408% higher).
The record links to 0 conditions, and to 2 interventions - of which anti-pseudomonal cephalosporin is the first listed.
NCT05094154 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05094154 about?
NCT05094154 is a clinical study titled "Effect of Antibiotic Choice On ReNal Outcomes (ACORN)". Sepsis is one of the most common causes of acute illness and death in the United States. Early, empiric broad-spectrum antibiotics are a mainstay of sepsis treatment. Two classes of antibiotics with activity against Pseudomonas, anti-pseudomonal cephalosporins and anti-pseudomonal penicillins, are c...
What is the current status of trial NCT05094154?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,634 participants. The study started on 2021-11-10. Estimated completion is 2022-10-21.
What interventions are being tested in trial NCT05094154?
The interventions under investigation include: anti-pseudomonal cephalosporin (DRUG), anti-pseudomonal penicillin (DRUG).
Who is sponsoring clinical trial NCT05094154?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05094154's enrollment target sits among peer trials
2,634 28th of 2000 higher than 1,973 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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