Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000566336
Ethics application status
Approved
Date submitted
19/04/2017
Date registered
24/04/2017
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Frusemide and Diamox Evaluation in ICU (FADE ICU) Study
Scientific title
A pilot comparative evaluation of the haemodynamic and electrolyte effects of Frusemide and Acetazolamide in critically ill patients
Secondary ID [1] 291711 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The FADE ICU Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney disease 302891 0
Condition category
Condition code
Renal and Urogenital 302372 302372 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single 500 milligram (mg) intravenous dose of Acetazolamide will be administered by an intensive care nurse following the prescription by the patient's treating intensive care doctor
Intervention code [1] 297793 0
Treatment: Drugs
Comparator / control treatment
A single 40 milligram (mg) intravenous dose of Frusemide will be administered by an intensive care nurse following the prescription by the patient's treating intensive care doctor
Control group
Active

Outcomes
Primary outcome [1] 301779 0
Urine volume
Timepoint [1] 301779 0
Volume of urine documented in the six hour period from the diuretic being administered as recorded in the patient's medical record
Secondary outcome [1] 333850 0
Systolic blood pressure change as assessed by intra-arterial blood pressure monitoring.
Timepoint [1] 333850 0
Systolic blood pressure recorded every 5 minutes for the six hour period from the diuretic being administered as recorded in the patient's medical record.
Secondary outcome [2] 333851 0
Heart rate change as assessed via continous electrocardiographic monitoring
Timepoint [2] 333851 0
Heart rate recorded every 5 minutes for the six hour period from the diuretic being administered as recorded in the patient's medical record.
Secondary outcome [3] 333852 0
Change in serum sodium (Na+) as measured via blood sample analysis
Timepoint [3] 333852 0
Change in serum sodium levels from immediately prior to the diuretic being administered compared with at six hours following the diuretic being administered as recorded in the patient's medical record.
Secondary outcome [4] 333853 0
Change in urinary sodium (Na+) as measured via urine sample analysis
Timepoint [4] 333853 0
Change in urinary sodium levels from immediately prior to the diuretic being administered compared with at six hours following the diuretic being administered as recorded in the patient's medical record.
Secondary outcome [5] 333854 0
Central venous pressure change as assessed via invasive central venous catheter monitoring.
Timepoint [5] 333854 0
Hourly for the first 6 hours after the administration of the diuretic as recorded in the patient's medical record.
Secondary outcome [6] 333946 0
Mean arterial blood pressure as assessed by intra-arterial blood pressure monitoring.
Timepoint [6] 333946 0
Mean arterial blood pressure recorded every 5 minutes for the six hour period from the diuretic being administered as recorded in the patient's medical record.
Secondary outcome [7] 333947 0
Change in serum creatinine
Timepoint [7] 333947 0
Change in serum creatinine levels from immediately prior to the diuretic being administered compared with at six hours following the diuretic being administered as recorded in the patient's medical record.
Secondary outcome [8] 333948 0
Urinary creatinine clearance
Timepoint [8] 333948 0
Change in urinary creatinine levels from immediately prior to the diuretic being administered compared with at six hours following the diuretic being administered as recorded in the patient's medical record.
Secondary outcome [9] 333961 0
Change in serum potassium (K+) as measured via blood sample analysis
Timepoint [9] 333961 0
Change in serum potassium levels from immediately prior to the diuretic being administered compared with at six hours following the diuretic being administered as recorded in the patient's medical record.
Secondary outcome [10] 333962 0
Change in serum calcium (Ca++) as measured via blood sample analysis
Timepoint [10] 333962 0
Change in serum calcium levels from immediately prior to the diuretic being administered compared with at six hours following the diuretic being administered as recorded in the patient's medical record.
Secondary outcome [11] 333963 0
Change in serum magnesium (Mg+) as measured via blood sample analysis
Timepoint [11] 333963 0
Change in serum magnesium levels from immediately prior to the diuretic being administered compared with at six hours following the diuretic being administered as recorded in the patient's medical record.
Secondary outcome [12] 333964 0
Change in urinary potassium (K+) as measured via urine sample analysis
Timepoint [12] 333964 0
Change in urinary potassium levels from immediately prior to the diuretic being administered compared with at six hours following the diuretic being administered as recorded in the patient's medical record.
Secondary outcome [13] 333965 0
Change in urinary calcium (Ca++) as measured via urine sample analysis
Timepoint [13] 333965 0
Change in urinary calcium levels from immediately prior to the diuretic being administered compared with at six hours following the diuretic being administered as recorded in the patient's medical record.
Secondary outcome [14] 333966 0
Change in urinary magnesium (Mg+) as measured via urine sample analysis
Timepoint [14] 333966 0
Change in urinary magnesium levels from immediately prior to the diuretic being administered compared with at six hours following the diuretic being administered as recorded in the patient's medical record.
Secondary outcome [15] 334845 0
Urinary oxygenation value
Timepoint [15] 334845 0
Change in urinary oxygenation value from the time of the insertion of the urinary oximetry probe and immediately prior to and six hours post diuretic administration as well as until it's removal in association with the routine insertion and use of a urinary catheter in critically ill patients admitted to the intensive care unit

Eligibility
Key inclusion criteria
Admission to the Austin Hospital ICU
Age 18 years or greater
An attending physician’s decision to administer a diuretic
An anticipated ICU length of stay of >24 hours after frusemide administration
Patients with existing intra-arterial cannulae or central venous catheters for blood sampling, and indwelling urinary catheters.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with known allergy to frusemide or acetazolamide or other sulphonamides.
Known existing end stage renal failure
Long-standing use of diuretic therapy
Dose of different diuretic in the preceding 12 hours.
Significant pre-existing acid-base disturbance at time of enrolment (pH < 7.30 or > 7.50)
Patient receiving continuous renal-replacement therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
Variables will be assessed for normality and log-transformed if appropriate. Baseline comparisons will be performed using Fisher’s exact tests and reported as n (%). Continuous normally distributed variables will be compared using Student t-tests and reported as means (standard deviation), while non-normally distributed data will be compared using Wilcoxon rank-sum tests and reported as medians [interquartile range].

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/04/2017
Actual
8/05/2017
Date of last participant enrolment
Anticipated
31/08/2017
Actual
30/03/2018
Date of last data collection
Anticipated
Actual
30/05/2018
Sample size
Target
24
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7847 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 15790 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 296212 0
Hospital
Name [1] 296212 0
Austin Hospital
Country [1] 296212 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 295119 0
Individual
Name [1] 295119 0
Professor Rinaldo Bellomo
Address [1] 295119 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country [1] 295119 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297450 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 297450 0
Ethics committee country [1] 297450 0
Australia
Date submitted for ethics approval [1] 297450 0
03/02/2017
Approval date [1] 297450 0
02/03/2017
Ethics approval number [1] 297450 0
HREC/17/Austin/75

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1720 1720 0 0
/AnzctrAttachments/372754-20170302 HREC17Austin75 Mar 17 (FULL ETHICS APPROVAL).pdf (Ethics approval)
Attachments [2] 1880 1880 0 0
/AnzctrAttachments/372754-20170630 HREC17austin75 July 17 (Ethics PA and PICF's).pdf (Ethics approval)

Contacts
Principal investigator
Name 74074 0
Prof Rinaldo Bellomo
Address 74074 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 74074 0
Australia
Phone 74074 0
+61 3 9496 5992
Fax 74074 0
+61 3 9496 3932
Email 74074 0
[email protected]
Contact person for public queries
Name 74075 0
Glenn Eastwood
Address 74075 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 74075 0
Australia
Phone 74075 0
+61 3 9496 4835
Fax 74075 0
+61 3 9496 3932
Email 74075 0
[email protected]
Contact person for scientific queries
Name 74076 0
Rinaldo Bellomo
Address 74076 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 74076 0
Australia
Phone 74076 0
+61 3 9496 4835
Fax 74076 0
+61 3 9496 3932
Email 74076 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.