Trial Review

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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).
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.
Secondary ID [1] 312423 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 334630 0
Chronic Kidney Disease 334629 0
Acute Kidney Injury 334631 0
Condition category
Condition code
Emergency medicine 331214 331214 0 0
Other emergency care
Infection 331310 331310 0 0
Studies of infection and infectious agents
Renal and Urogenital 332044 332044 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 329250 0
Early Detection / Screening
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.
Control group
Historical

Outcomes
Primary outcome [1] 338985 0
The occurrence of AKI following a single dose of aminoglycosides in patients with CKD compared to patients without CKD
Timepoint [1] 338985 0
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).
Secondary outcome [1] 438190 0
Severity of AKI as classified by KDIGO guidelines,
Timepoint [1] 438190 0
Discharge of patient from hospital.
Secondary outcome [2] 438990 0
ICU admission rate
Timepoint [2] 438990 0
during the admission when aminoglycoside dose was given in ED
Secondary outcome [3] 438991 0
need for renal replacement therapy (RRT).
Timepoint [3] 438991 0
during the admission when aminoglycoside was given in ED
Secondary outcome [4] 438989 0
mortality (during hospital stay),
Timepoint [4] 438989 0
during admission when they were given aminoglycosides

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who received multiple doses of aminoglycosides.
- Patients without baseline creatinine levels.
- Patients without weight records.
- Patients on haemodialysis.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
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.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
31/07/2024
Date of last participant enrolment
Anticipated
Actual
30/08/2024
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
660
Accrual to date
Final
660
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26893 0
Casey Hospital - Berwick
Recruitment hospital [2] 26892 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [3] 26891 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [4] 26894 0
Victorian Heart Hospital - Clayton
Recruitment postcode(s) [1] 42954 0
3806 - Berwick
Recruitment postcode(s) [2] 42952 0
3168 - Clayton
Recruitment postcode(s) [3] 42953 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 316836 0
Self funded/Unfunded
Name [1] 316836 0
Country [1] 316836 0
Primary sponsor type
Hospital
Name
Monash Health
Address
Country
Australia
Secondary sponsor category [1] 319068 0
Government body
Name [1] 319068 0
Monash Health
Address [1] 319068 0
Country [1] 319068 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315604 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315604 0
Ethics committee country [1] 315604 0
Australia
Date submitted for ethics approval [1] 315604 0
23/07/2024
Approval date [1] 315604 0
31/07/2024
Ethics approval number [1] 315604 0
RES-24-0000-603Q

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135222 0
Ms Grace Lau
Address 135222 0
Victorian Heart Hospital, Pharmacy Department, 631 Blackburn Road, Victoria, 3168
Country 135222 0
Australia
Phone 135222 0
+61 3 75111111
Fax 135222 0
Email 135222 0
[email protected]
Contact person for public queries
Name 135223 0
Grace Lau
Address 135223 0
Victorian Heart Hospital, Pharmacy Department, 631 Blackburn Road, Victoria.3168
Country 135223 0
Australia
Phone 135223 0
+61 3 75111111
Fax 135223 0
Email 135223 0
[email protected]
Contact person for scientific queries
Name 135224 0
Grace Lau
Address 135224 0
Victorian Heart Hospital, Pharmacy Department,631 Blackburn Road, Victoria.3168
Country 135224 0
Australia
Phone 135224 0
+61 3 75111111
Fax 135224 0
Email 135224 0
[email protected]

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.