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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05468203




Registration number
NCT05468203
Ethics application status
Date submitted
19/07/2022
Date registered
21/07/2022
Date last updated
1/12/2023

Titles & IDs
Public title
PREVENTion With Sglt-2 Inhibition of Acute Kidney Injury in Intensive Care
Scientific title
PREVENTion With Sglt-2 Inhibition of Acute Kidney Injury in Intensive Care
Secondary ID [1] 0 0
GI-RM-7738
Universal Trial Number (UTN)
Trial acronym
PREVENTS-AKI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Kidney Injury 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dapagliflozin 10mg Tab
Treatment: Drugs - Placebo

Experimental: Dapagliflozin - Dapaliflozin 10mg tablet administered once daily while in ICU for up to 30 days

Placebo comparator: Matched Placebo - Matched placebo tablet administered once daily while in ICU for up to 30 days


Treatment: Drugs: Dapagliflozin 10mg Tab
Patients will be randomly assigned to receive either dapagliflozin 10 mg or placebo daily while in ICU for up to 30 days

Treatment: Drugs: Placebo
Patients will be randomly assigned to receive either dapagliflozin 10 mg or placebo daily while in ICU for up to 30 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite outcome: Doubling of serum creatinine from baseline, initiation of renal replacement therapy or death
Timepoint [1] 0 0
Within 30 days of randomisation
Secondary outcome [1] 0 0
Doubling of Serum Creatinine
Timepoint [1] 0 0
Within 30 days of randomisation
Secondary outcome [2] 0 0
Requirement of Renal Replacement Therapy (RRT)
Timepoint [2] 0 0
Within 30 days of randomisation
Secondary outcome [3] 0 0
All-cause mortality
Timepoint [3] 0 0
Within 30 days of randomisation
Secondary outcome [4] 0 0
Vasoactive drug therapy
Timepoint [4] 0 0
Within 30 days of randomisation
Secondary outcome [5] 0 0
Mechanical ventilation
Timepoint [5] 0 0
Within 30 days of randomisation
Secondary outcome [6] 0 0
Ventricular tachycardia or ventricular fibrillation
Timepoint [6] 0 0
Within 30 days of randomisation

Eligibility
Key inclusion criteria
* Age 18 years or more
* Admitted to ICU within the last 7 days
* Expected to be in the ICU the day after tomorrow
* An arterial or central venous catheter is in situ, or placement is planned for routine management
* Able to receive study treatment orally or via enteral route
* At least one of the following risk factors for AKI:

* Required fluid resuscitation, defined as a bolus of fluid prescribed to be given over =1 hour to increase or maintain intravascular volume that is in addition to maintenance fluids
* Being treated with continuous vasopressors or inotropes to maintain a systolic blood pressure > 90mmHg, or mean arterial blood pressure > 60mmHg or a MAP target set by the treating clinician for maintaining perfusion
* At least one of the following pre-morbid risk factors:

* Treatment for high blood pressure
* Treatment for type 2 diabetes (minimum diet therapy)
* Atherosclerotic cardiovascular disease
* History of heart failure
* Impaired renal function, defined as an eGFR between 20 - 60 mL/min/1.73m2
* Estimated BMI 30 kg/m2 or more
* Age 60 years or more
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Met all inclusion criteria more than 24 hours ago
* History of type 1 diabetes mellitus or diabetic ketoacidosis
* COVID-19 infection as the reason for ICU admission
* Requiring renal replacement therapy for intoxication
* eGFR less than 20 mL/min/1.73m2
* Known hypersensitivity to any SGLT-2 inhibitor e.g. dapagliflozin, canagliflozin, empagliflozin, ertugliflozin
* Solid organ transplantation within the last 12 months
* Likely to be transferred to another hospital in the next 3 days
* Known or suspected pregnancy
* Death is deemed imminent or inevitable
* Life expectancy is estimated to be less than 90 days
* Patient or the treating clinician declines to participate
* Enrolled in another interventional trial for which co-enrolment is not approved
* Patient has previously been enrolled in the PREVENTS-AKI Study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Grampians Health - Ballarat
Recruitment hospital [2] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University Medical Center Groningen
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian and New Zealand Intensive Care Society Clinical Trials Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Martin P Gallagher, MBBS, FRACP
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Coggan, BSc, MPH
Address 0 0
Country 0 0
Phone 0 0
02 9993 4566
Fax 0 0
Email 0 0
scoggan@georgeinstitute.org.au
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05468203