Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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:
Chronic Kidney Disease 334629 0
Sepsis 334630 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
Assessment method [1] 338985 0
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.
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,
Assessment method [1] 438190 0
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.
Timepoint [1] 438190 0
Discharge of patient from hospital.
Secondary outcome [2] 438989 0
mortality (during hospital stay),
Assessment method [2] 438989 0
as per medical records
Timepoint [2] 438989 0
during admission when they were given aminoglycosides
Secondary outcome [3] 438990 0
ICU admission rate
Assessment method [3] 438990 0
as per medical records
Timepoint [3] 438990 0
during the admission when aminoglycoside dose was given in ED
Secondary outcome [4] 438991 0
need for renal replacement therapy (RRT).
Assessment method [4] 438991 0
As per medical records
Timepoint [4] 438991 0
during the admission when aminoglycoside was given in ED

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] 26891 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 26892 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [3] 26893 0
Casey Hospital - Berwick
Recruitment hospital [4] 26894 0
Victorian Heart Hospital - Clayton
Recruitment postcode(s) [1] 42952 0
3168 - Clayton
Recruitment postcode(s) [2] 42953 0
3175 - Dandenong
Recruitment postcode(s) [3] 42954 0
3806 - Berwick

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
Country
Australia
Secondary sponsor category [1] 319068 0
Government body
Name [1] 319068 0
Monash Health
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
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
Email 135222 0
grace.lau@monashhealth.org
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
Email 135223 0
grace.lau@monashhealth.org
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
Email 135224 0
grace.lau@monashhealth.org

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.