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Trial registered on ANZCTR
Registration number
ACTRN12624001068550
Ethics application status
Approved
Date submitted
19/08/2024
Date registered
3/09/2024
Date last updated
22/09/2024
Date data sharing statement initially provided
3/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A Pilot, Two-Centre, Open-Label, Safety and Physiological Efficacy Randomised Controlled Trial of Intravenous Amino Acid Therapy in Vasopressor-Dependent Adults Admitted to the Intensive Care Unit
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Scientific title
A Pilot, Two-Centre, Open-Label, Safety and Physiological Efficacy Randomised Controlled Trial of Intravenous Amino Acid Therapy in Vasopressor-Dependent Adults Admitted to the Intensive Care Unit
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Secondary ID [1]
312501
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical illness
334379
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Condition category
Condition code
Cardiovascular
331017
331017
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Synthamin-17 without electrolytes will be administered as a single continuous Intravenous infusion for 36 hours at a dose of 2 g/kg/day of ideal body weight (to a maximum of 100 g/day) that will be commenced and only given while the participant is in the intensive care unit. Adherence will be monitored via electronic medical record review. The composition of Synthamin-17 10% without electrolytes is:
- The excipients are sodium metabisulfite, acetic acid and water for injection.
- Essential amino acids: Leucine 7.30 g, Phenylalanine 5.60 g, Methionine 4.00 g, Lysine (as the hydrochloride salt) 5.80 g, Isoleucine 6.00 g, Valine 5.80 g, Histidine 4.80 g, Threonine 4.20 g, Tryptophan 1.80 g.
- Non-essential amino acids: Alanine 20.7 g, Glycine 10.3 g, Arginine 11.5 g, Proline 6.80 g, Tyrosine 400 mg, Serine 5.00 g.
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Intervention code [1]
329028
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Treatment: Other
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Comparator / control treatment
Compound Sodium Lactate (Hartmann's solution) for 36 hours at a rate that is associated with the delivery of 2g/kg/ideal body weight/day (to a maximum of 100g/day.
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Control group
Active
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Outcomes
Primary outcome [1]
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The difference between baseline creatinine clearance and creatinine clearance at 36 hours after initiation of the study infusion between patients receiving amino acid vs a balanced crystalloid infusion
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Assessment method [1]
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Biochemical analysis of blood pathology as recorded in the participants electronic medical record
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Timepoint [1]
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Baseline (pre-initiation) and at 36 hours after initiation of the study infusion.
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Secondary outcome [1]
437410
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Cumulative urine output in millilitres over 36 hours after initiation of the study infusion
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Assessment method [1]
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Electronic medical record review
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Timepoint [1]
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Total volume of urine at 36 hours after initiation of the study infusion
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Secondary outcome [2]
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Serum creatinine at 36 hours after initiation of the study infusion
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Assessment method [2]
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Electronic medical record review
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Timepoint [2]
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Baseline (pre-initiation) and at 36 hours after initiation of the study infusion
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Secondary outcome [3]
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Plasma cystatin C at 36 hours after initiation of the study infusion
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Assessment method [3]
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Electronic medical record review
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Timepoint [3]
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Baseline (pre-initiation) and at 36 hours after initiation of the study infusion
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Secondary outcome [4]
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Urinary neutrophil gelatinase-associated lipocalin (NGAL)
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Assessment method [4]
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Electronic medical record review
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Timepoint [4]
437437
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Baseline (pre-initiation) and at 36 hours after initiation of the study infusion
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Secondary outcome [5]
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Urine albumin/creatinine ratio at 36 hours after initiation of the study infusion
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Assessment method [5]
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Electronic medical record review
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Timepoint [5]
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Baseline (pre-initiation) and at 36 hours after initiation of the study infusion
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Secondary outcome [6]
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Urinary electrolytes at 36 hours after initiation of the study infusion
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Assessment method [6]
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Electronic medical record review
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Timepoint [6]
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Baseline (pre-initiation) and at 36 hours after initiation of the study infusion
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Secondary outcome [7]
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Maximum severity of acute kidney injury up to day 7 (defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
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Assessment method [7]
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Electronic medical record review
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Timepoint [7]
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7 days after enrolment
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Secondary outcome [8]
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Duration of acute kidney injury up to day 30
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Assessment method [8]
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Electronic medical record review
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Timepoint [8]
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30 days after enrolment
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Secondary outcome [9]
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Occurrence of acute kidney disease (AKD) (defined by the Acute Dialysis Quality Initiative – ADQI criteria)
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Assessment method [9]
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Electronic medical record review
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Timepoint [9]
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Hospital discharge
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Secondary outcome [10]
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Need for renal replacement therapy (RRT) up to day 30
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Assessment method [10]
437443
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Electronic medical record review
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Timepoint [10]
437443
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30 days after enrolment
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Secondary outcome [11]
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Days alive and renal replacement therapy-free to day 30
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Assessment method [11]
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Electronic medical record review
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Timepoint [11]
437444
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30 days after enrolment
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Secondary outcome [12]
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Days alive and AKI free to day 7
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Assessment method [12]
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Electronic medical record review
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Timepoint [12]
437445
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7 days after enrolment.
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Secondary outcome [13]
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Days alive and AKD free to day 30
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Assessment method [13]
437446
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Electronic medical record review
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Timepoint [13]
437446
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30 days after enrolment
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Secondary outcome [14]
437447
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ICU length of stay in days
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Assessment method [14]
437447
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Electronic medical record review
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Timepoint [14]
437447
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ICU discharge
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Secondary outcome [15]
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Hospital length of stay in days
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Assessment method [15]
437448
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Electronic medical record review
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Timepoint [15]
437448
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Hospital discharge
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Secondary outcome [16]
437449
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Days alive and ICU free to day 30
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Assessment method [16]
437449
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Electronic medical record review
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Timepoint [16]
437449
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30 days after enrolment
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Secondary outcome [17]
437450
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Days alive and ICU free to day 30
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Assessment method [17]
437450
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Electronic medical record review
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Timepoint [17]
437450
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30 days after enrolment
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Secondary outcome [18]
437451
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ICU mortality
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Assessment method [18]
437451
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Electronic medical record review
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Timepoint [18]
437451
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ICU discharge
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Secondary outcome [19]
437452
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Hospital mortality
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Assessment method [19]
437452
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Electronic medical record review
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Timepoint [19]
437452
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Hospital discharge
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Eligibility
Key inclusion criteria
Adult aged equal to or greater than 18 years
Admitted to the intensive care unit for less than 72 hours
Receiving vasopressor therapy and expected to continue for 24 hours
The patient is expected to remain in ICU for greater than 24 hours
Appropriate intravascular device, such as a central line or peripherally inserted central catheter, to administer the intervention
Appropriate devices to collect samples; arterial line and indwelling urinary catheter
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Severe Acute kidney injury, as defined by Kidney Disease Improving Global Outcomes (KDIGO) stage 3 criteria
Requirement for renal replacement thearapy, such as dialysable toxin
Urea greater than 30 mmol/L
Absence of a central access device
Already of vasopressor therapy for greater than 24 hours
Pre-admission chronic kidney disease with an estimated glomerular filtration rate of less than of less than 30 ml/min
Acute estimated glomerular filtration rate of less than 30 ml/min
Chronic haemodialysis or peritoneal dialysis
Need for extracorporeal membrane oxygenation
Previous enrolment in this study
Pregnant or lactating
Patients who are not to receive full active treatment
Transferred from another intensive care unit
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A centralised, web-based system (REDCap) will be employed, allowing 24-hour enrolment and random allocation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence will be generated using a computer software program and embedded into the REDCap system. Site investigators, site research coordinators, and study participants will not have access to the allocation sequence.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
A statistician will perform data analysis on an intention-to-treat basis. Summary statistics will describe the clinical data and be presented as mean ± SD, median with interquartile range (IQR) or percentages as appropriate. Chi-squared analysis with Fisher’s exact test (when appropriate), and Student’s t-test (Mann Whitney U test for non-normal distributions) or mixed linear models for repeated measurements will be used to compare data between the active treatment group and the control group with statistical significance declared for probability values of 0.05 or less. The outcome of excluded patients (e.g., due to other trials) will be analysed per the CONSORT guidelines. A complete and finalised statistical analysis plan will be prepared and made available before the recruitment.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2024
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Actual
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Date of last participant enrolment
Anticipated
31/10/2025
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
26775
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [2]
26776
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
42826
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3084 - Heidelberg
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Recruitment postcode(s) [2]
42827
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4102 - Woolloongabba
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
316923
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Austin Hospital
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Address [1]
316923
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Country [1]
316923
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Australia
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Primary sponsor type
Hospital
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Name
Austin Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
319177
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Individual
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Name [1]
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Professor Rinaldo Bellomo
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Address [1]
319177
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Country [1]
319177
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315677
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
315677
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https://www.austin.org.au/Office-for-Research/
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Ethics committee country [1]
315677
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Australia
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Date submitted for ethics approval [1]
315677
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22/07/2024
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Approval date [1]
315677
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19/09/2024
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Ethics approval number [1]
315677
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Summary
Brief summary
Acute kidney injury is common in critically ill patients, especially in those requiring vasopressor therapy. We hypothesize that an intravenous infusion of amino acids in such patients will increase glomerular function without tubular injury when compared to a balanced crystalloid solution of equal volume. In this two-centre, pilot safety and efficacy randomised controlled trial we plan to enrol 60 adult patients with the study drug delivered via infusion while the participant is in the intensive care unit.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Rinaldo Bellomo
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Address
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Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
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Country
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Australia
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Phone
135474
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+61 394965992
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Fax
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Email
135474
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[email protected]
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Contact person for public queries
Name
135475
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Rinaldo Bellomo
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Address
135475
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Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
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Country
135475
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Australia
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Phone
135475
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+61 394965992
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Fax
135475
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Email
135475
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[email protected]
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Contact person for scientific queries
Name
135476
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Rinaldo Bellomo
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Address
135476
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Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
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Country
135476
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Australia
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Phone
135476
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+61 394965992
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Fax
135476
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Email
135476
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Ethics approval not sought for sharing of patient data
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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.
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