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Trial registered on ANZCTR
Registration number
ACTRN12625000195459
Ethics application status
Approved
Date submitted
9/08/2024
Date registered
20/02/2025
Date last updated
20/02/2025
Date data sharing statement initially provided
20/02/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Safety of Single Aminoglycoside Dose among patient with chronic kidney disease in the Emergency Department (SAD-ED).
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Scientific title
The Occurrence of AKI with Single Aminoglycoside Dose in the Emergency Department (SAD-ED) study in Patients with Chronic Kidney Disease: retrospective cohort study.
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Secondary ID [1]
312423
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sepsis
334630
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Chronic Kidney Disease
334629
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Acute Kidney Injury
334631
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Condition category
Condition code
Emergency medicine
331214
331214
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0
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Other emergency care
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Infection
331310
331310
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0
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Studies of infection and infectious agents
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Renal and Urogenital
332044
332044
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0
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Kidney disease
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This is a retrospective study of all ED patients who have received a single-dose IV aminoglycoside (gentamicin, tobramycin, amikacin) irrespective of the dose given. All data will be extracted of existing medical records.
Primary study outcome is the proportion of patients with acute kidney injury (AKI) among individuals with CKD compared to those without CKD.
Data will be collected for patients treated at study site between 2019 after EMR implementation up to July 2024.
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Intervention code [1]
329250
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Early Detection / Screening
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Comparator / control treatment
ED patients who received a single-dose aminoglycoside who have normal kidney function versus chronic kidney disease (CKD) GFR category 1-2, (eGFR=60mL/min/1.73 m2)
The comparator arm is ED patients who received a single-dose aminoglycoside who have normal kidney function.
The data will be collected from the time EMR was introduced at the network in January/2019 until July/2024 from the Monash Health medical record database.
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Control group
Historical
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Outcomes
Primary outcome [1]
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The occurrence of AKI following a single dose of aminoglycosides in patients with CKD compared to patients without CKD
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Assessment method [1]
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Liaise with informatics team to extract a list of patients who have been to ED between the years of 2019 after electronic medical record (EMR) system implementation up to July 2024, and who have been charted and administered a dose of an aminoglycoside. All data will be collected in a de-identified manner and entered electronically into an Excel data collection file.
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Timepoint [1]
338985
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The identification of AKI will be based KDIGO guidelines: an increase in serum creatinine by at least 26.5 micromol/L or 1.5 times baseline as measured within the first 48-72 hours (KDIGO definition: within 48 hours).
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Secondary outcome [1]
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Severity of AKI as classified by KDIGO guidelines,
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Assessment method [1]
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Stages of AKI based on KDIGO Classification Stage 1: Increase in SCr = 0.3 mg/dL (in 48 hours) or 1.5 to 1.9 multiplied by baseline (in 7 days); Stage 2: 2.0 to 2.9 multiplied by baseline SCr; Stage 3: 3.0 or more multiplied by baseline; increase in SCr = 4.0 mg/dL; or beginning of renal replacement therapy regardless of a previous KDIGO stage. This data will be collected from patients' medical records.
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Timepoint [1]
438190
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Discharge of patient from hospital.
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Secondary outcome [2]
438990
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ICU admission rate
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Assessment method [2]
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as per medical records
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Timepoint [2]
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during the admission when aminoglycoside dose was given in ED
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Secondary outcome [3]
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need for renal replacement therapy (RRT).
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Assessment method [3]
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As per medical records
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Timepoint [3]
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during the admission when aminoglycoside was given in ED
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Secondary outcome [4]
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mortality (during hospital stay),
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Assessment method [4]
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as per medical records
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Timepoint [4]
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during admission when they were given aminoglycosides
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Eligibility
Key inclusion criteria
- Patients with CKD (eGFR < 60mL/min) who have received a single dose of an aminoglycoside (tobramycin, amikacin, gentamicin) irrespective of dose within the Emergency Departments across Monash Health (Monash Medical Centre Clayton, Dandenong, Casey, Victorian Heart Hospital).
The identification of CKD will be based on KDIGO guidelines: GFR <60 mL/min/1.73m2 (GFR categories G3a–G5) for a minimum of 3 months.11
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients who received multiple doses of aminoglycosides.
- Patients without baseline creatinine levels.
- Patients without weight records.
- Patients on haemodialysis.
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
Data will be analysed using SPSS package (version 25).
The primary outcome and all bivariate outcomes will be analysed using the Chi-squared test. Continuous data analysis will be assessed for distribution using Kolmogorov-Smirnov test, then significance checked using student t test or Mann-Whitney U test depending on distribution results.
Analysis of confounding medical conditions and concurrent nephrotoxins on AKI rates will be examined in post-hoc
analysis.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
31/07/2024
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Date of last participant enrolment
Anticipated
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Actual
30/08/2024
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
660
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Accrual to date
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Final
660
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Casey Hospital - Berwick
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Recruitment hospital [2]
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Dandenong Hospital- Monash Health - Dandenong
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Recruitment hospital [3]
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [4]
26894
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Victorian Heart Hospital - Clayton
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Recruitment postcode(s) [1]
42954
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3806 - Berwick
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Recruitment postcode(s) [2]
42952
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3168 - Clayton
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Recruitment postcode(s) [3]
42953
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3175 - Dandenong
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
316836
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Country [1]
316836
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Primary sponsor type
Hospital
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Name
Monash Health
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Address
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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Monash Health
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Address [1]
319068
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Country [1]
319068
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315604
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
315604
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https://www.monash.edu/researchoffice/ethics
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Ethics committee country [1]
315604
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Australia
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Date submitted for ethics approval [1]
315604
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23/07/2024
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Approval date [1]
315604
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31/07/2024
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Ethics approval number [1]
315604
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RES-24-0000-603Q
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Summary
Brief summary
The research project aims to determine the safety of commonly used antibiotics in emergency departments among patient with and without chronic kidney disease, to determine if these antibiotics (gentamicin, tobramycin and amikacin) increase the risk of acute kidney injury in patients with chronic kidney disease.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Grace Lau
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Address
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Victorian Heart Hospital, Pharmacy Department, 631 Blackburn Road, Victoria, 3168
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Country
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Australia
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Phone
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+61 3 75111111
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Fax
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Email
135222
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[email protected]
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Contact person for public queries
Name
135223
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Grace Lau
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Address
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Victorian Heart Hospital, Pharmacy Department, 631 Blackburn Road, Victoria.3168
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Country
135223
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Australia
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Phone
135223
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+61 3 75111111
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Fax
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Email
135223
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[email protected]
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Contact person for scientific queries
Name
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Grace Lau
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Address
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Victorian Heart Hospital, Pharmacy Department,631 Blackburn Road, Victoria.3168
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Country
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Australia
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Phone
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+61 3 75111111
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Fax
135224
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Email
135224
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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