Trial · NCT05094154
Effect of Antibiotic Choice On ReNal Outcomes (ACORN)
NCT05094154, Phase 4, Completed, Vanderbilt University Medical Center; results first posted 2023-12-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Antibiotic Choice On ReNal Outcomes (ACORN). Trials, record NCT05094154. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05094154
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Antibiotic Choice On ReNal Outcomes (ACORN)
- NCT number
- NCT05094154
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,634 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Sepsis, AKI, Neurotoxicity
- Interventions
- anti-pseudomonal cephalosporin, anti-pseudomonal penicillin
- First posted
- 2021-10-26
- Last updated
- 2023-12-22
- Results first posted
- 2023-12-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Acute Kidney Injury (AKI) Ordinal Scale | 14 days post-enrollment | 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 baseline OR increase to \>= 4.0 mg/dL OR New RRT) 4. = Death |
| Secondary | Major Adverse Kidney Events Within 14 Days (MAKE14) | 14 days post-enrollment | Composite outcome of death within 14 days, new renal replacement therapy within 14 days, or stage 2 or higher AKI at day 14 |
| Secondary | Delirium and Coma-Free Days to Day 14 | 14 days post-enrollment | The number of days alive and free of coma and delirium in the 14 days after enrollment |
| Other | Post-Emergency Department Disposition | 14 days post-enrollment | Patient disposition (ex. floor unit or intensive care unit) at day 14 post-enrollment from the emergency department. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Acute Kidney Injury (AKI) Ordinal Scale | 14 days post-enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Major Adverse Kidney Events Within 14 Days (MAKE14) | 14 days post-enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Delirium and Coma-Free Days to Day 14 | 14 days post-enrollment | days | MEDIAN | |
| OTHER_PRE_SPECIFIED | Post-Emergency Department Disposition | 14 days post-enrollment | participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Acute Kidney Injury (AKI) Ordinal Scale | Anti-pseudomonal Cephalosporin | 0 = Survived without AKI | 910 | Participants | |
| Acute Kidney Injury (AKI) Ordinal Scale | Anti-pseudomonal Penicillin | 0 = Survived without AKI | 952 | Participants | |
| Acute Kidney Injury (AKI) Ordinal Scale | Anti-pseudomonal Cephalosporin | 1 = Survived with Stage 1 AKI | 86 | Participants | |
| Acute Kidney Injury (AKI) Ordinal Scale | Anti-pseudomonal Penicillin | 1 = Survived with Stage 1 AKI | 100 | Participants | |
| Acute Kidney Injury (AKI) Ordinal Scale | Anti-pseudomonal Cephalosporin | 2 = Survived with Stage 2 AKI | 41 | Participants | |
| Acute Kidney Injury (AKI) Ordinal Scale | Anti-pseudomonal Penicillin | 2 = Survived with Stage 2 AKI | 70 | Participants | |
| Acute Kidney Injury (AKI) Ordinal Scale | Anti-pseudomonal Cephalosporin | 3 = Survived with Stage 3 AKI | 85 | Participants | |
| Acute Kidney Injury (AKI) Ordinal Scale | Anti-pseudomonal Penicillin | 3 = Survived with Stage 3 AKI | 97 | Participants | |
| Acute Kidney Injury (AKI) Ordinal Scale | Anti-pseudomonal Cephalosporin | 4 = Died | 92 | Participants | |
| Acute Kidney Injury (AKI) Ordinal Scale | Anti-pseudomonal Penicillin | 4 = Died | 78 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anti-pseudomonal Cephalosporin | 1,277 | |
| Overall Study | STARTED | Anti-pseudomonal Penicillin | 1,357 | |
| Overall Study | COMPLETED | Anti-pseudomonal Cephalosporin | 1,214 | |
| Overall Study | COMPLETED | Anti-pseudomonal Penicillin | 1,297 | |
| Overall Study | NOT COMPLETED | Anti-pseudomonal Cephalosporin | 63 | |
| Overall Study | NOT COMPLETED | Anti-pseudomonal Penicillin | 60 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood product related allergy | Immune system disorders | Anti-pseudomonal Cephalosporin | 0 | 1,214 | 0 |
| other | Blood product related allergy | Immune system disorders | Anti-pseudomonal Penicillin | 1 | 1,297 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anti-pseudomonal Cephalosporin | 104 | 1,214 |
| Total, all-cause mortality | Anti-pseudomonal Penicillin | 106 | 1,297 |
| Total, other adverse events | Anti-pseudomonal Cephalosporin | 0 | 1,214 |
| Total, other adverse events | Anti-pseudomonal Penicillin | 1 | 1,297 |
| Total, serious adverse events | Anti-pseudomonal Cephalosporin | 0 | 1,214 |
| Total, serious adverse events | Anti-pseudomonal Penicillin | 0 | 1,297 |
Source ClinicalTrials.gov
Papers26
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Anti-pseudomonal Cephalosporin vs Anti-pseudomonal Penicillin: Major Adverse Kidney Events Within 14 Days (MAKE14) | Trial comparisons |
| Anti-pseudomonal Cephalosporin vs Anti-pseudomonal Penicillin: deaths from any cause | Trial comparisons |
| Anti-pseudomonal Cephalosporin vs Anti-pseudomonal Penicillin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05094154
GET https://conductscience.org/api/trials/v1/NCT05094154/papers?page=2