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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
Background Acute Kidney Injury (AKI) is a potentially life-threatening condition caused by unsafe levels of fluid and waste products accumulating in the body. Often, patients with AKI need treatment with an artificial kidney (called renal replacement therapy or dialysis) to do the work of their kidneys and remove these dangerous levels of fluid and waste from the body. If left untreated, AKI can become a chronic (long-term) condition that may require treatment for life.

Dapagliflozin is a medication used to treat patients with diabetes, heart disease and long-term (chronic) kidney disease. Recently, Dapagliflozin has been shown to slow the progression of other kidney related complications, however this has not yet been studied in critically ill patients.

Aim To determine if giving Dapagliflozin (one tablet a day) compared to placebo (a tablet that looks identical but has no active ingredients), decreases injury to the kidneys in patients admitted to the Intensive Care Unit.

Design This study will enrol 3000 patients from 45-50 hospitals worldwide. It is a 'randomised controlled trial' meaning patients will be randomly assigned (like tossing a coin) by a computer to receive either Dapagliflozin or placebo for a maximum of 30 days whilst in the ICU. The study is also a 'double blinded trial' meaning that neither the doctor, the intensive care staff or the patient will know which study treatment they are receiving.
Trial website
https://clinicaltrials.gov/study/NCT05468203
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05468203