Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001015235
Ethics application status
Not yet submitted
Date submitted
20/11/2009
Date registered
23/11/2009
Date last updated
23/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Nephro-protective effects of L-amino acids in critically ill patients. A phase II multicentre randomised controlled trial.
Scientific title
Nephro-protective effects of L-amino acids versus standard care/usual care in critically ill adult patients at risk of developing acute kidney injury. A phase II multi-centre randomised controlled trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness Intensive Care Unit (ICU) Patients 252249 0
Condition category
Condition code
Renal and Urogenital 252437 252437 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supplementary infusion of L-amino acids to achieve 2g/kg/day total protein intake on each day for the entire duration of Intensive Care Unit (ICU) stay
Intervention code [1] 241563 0
Treatment: Other
Comparator / control treatment
Standard Care / Usual Care, which encompasses all aspects of standard/usual care delivered for the entire duration of Intensive Care Unit (ICU) stay
Control group
Active

Outcomes
Primary outcome [1] 253285 0
Number of days of clinically significant renal dysfunction, assessed and defined using the Brussels Table standards (Bernard GR, Doig GS, Hudson LD et al. Quantification of organ failure for clinical trials and clinical practice. Am J Resp Crit Care Med 1995;151:A323).
Timepoint [1] 253285 0
During ICU stay
Secondary outcome [1] 262300 0
Severity of renal dysfunction, assessed and defined using the Acute Dialysis Quality Initiative's published criteria (Bellomo R, Ronco C, Kellum JA et al. Acute renal failure-definition, outcome measures, animal models, fluid therapy and information technology needs:The second International Consensus Conference of the Acute Dialysis Quality Initiative Group. Crit Care 2004;8:R204-212).
Timepoint [1] 262300 0
Measured during ICU stay
Secondary outcome [2] 262301 0
Number of days of renal replacement therapy (RRT) delivered. Assessed by prospectively observing and recording renal replacement therapy (RRT) delivered to enrolled patients.
Timepoint [2] 262301 0
Measured during ICU stay
Secondary outcome [3] 262302 0
Dose of renal replacement therapy delivered. Assessed by prospectively observing and recording the mls/kg/hour of renal replacment therapy (RRT) delivered to enrolled patients.
Timepoint [3] 262302 0
Measured during ICU stay
Secondary outcome [4] 262368 0
Quality of Life assessed using Short Form (SF)-36 questionnaire
Timepoint [4] 262368 0
Measured at day 90 post randomisation into the trial
Secondary outcome [5] 262369 0
Physical Function measured using the physical function component of the Short Form (SF)-36 questionnaire
Timepoint [5] 262369 0
Measured at day 90 post randomisation into the trial
Secondary outcome [6] 262370 0
Need for Dialysis- i.e. is the patient receiving, or scheduled to receive, any form of dialysis (continuous haemodialysis, intermittent peritoneal dialysis etc) at day 90
Timepoint [6] 262370 0
Measured at day 90 post randomisation into the trial
Secondary outcome [7] 262371 0
Duration of ICU and Hospital Stay. Assessed by prospectively observing and recording Intensive Care Unit (ICU) and Hospital Stay.
Timepoint [7] 262371 0
Measured at Intensive Care Unit (ICU) and Hospital Discharge
Secondary outcome [8] 262372 0
Duration of Mechanical Ventilation. Assessed by prospectively observing and recording Mechanical Ventilation delivered to enrolled patients.
Timepoint [8] 262372 0
Measured during ICU stay
Secondary outcome [9] 262373 0
Days of antibiotic use. Assessed by prospectively observing and recording Antibiotics delivered to enrolled patients on each day of Intensive Care Unit (ICU) stay.
Timepoint [9] 262373 0
Measured during ICU stay

Eligibility
Key inclusion criteria
Patients will be screened for eligibility within 24hrs of admission to study Intensive Care Unit (ICU). Patients will be considered eligible for the trial if all of the following inclusion criteria are met at the time of screening: 1)Presence of a central venous access line through which the study intervention could be delivered; 2)Expected to remain in the ICU for at least 3 days; 3)At least 18yrs of age; 4)Admitted to the study ICU for less than 24hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be considered ineligible for the trial if any of the following exclusion criteria are met at the time of screening: 1)Receiving an non steroidal anti-inflammatory drugs (NSAID) with specific emphasis on COX-2 inhibitors; 2)Receiving a nitrous oxide (NO) inhibitor; 3)Receiving a diuretic that acts on the proximal tubule (Ex. acetazolaminde); 4)Pre-existing chronic kidney disease; 5)Pre-existing ongoing need for chronic dialysis; 6)Recent kidney transplant; 7)Intensive Care Unit (ICU) length of stay at the time of screening is greater than 24hrs; 8)Admitted to the Intensive Care Unit (ICU) for palliative care and is not expected to survive to hospital discharge; 9)Moribund and not expected to survive 24hrs; 10)Brain dead or suspected to be brain dead; 11)Admitted to the study Intensive Care Unit (ICU) directly from another ICU; 12)Documented contraindications to the study intervention (Intravenous (IV) L-amino acids), as listed on the Therapeutic Goods Administration (TGA) product licensing document; or 13)Clinically significant acute kidney injury at the time of screening.

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)
Centralised randomisation by computer using a password protected webserver.
As in any centralised method, individual patient treatment assignment will not be revealed until the potential participant is determined to be truely eligible for the trial and patient identifiers are submitted over the web to the centralised computer.
Persons recruiting patients into the trial will not be able to predict or influence treatment assignments, hence allocation is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised (SAS)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
474
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244036 0
Government body
Name [1] 244036 0
National Health & Medical Research Council (NHMRC)
Country [1] 244036 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council (NHMRC)
Address
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 251413 0
None
Name [1] 251413 0
Address [1] 251413 0
Country [1] 251413 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258135 0
Ethics committee address [1] 258135 0
Ethics committee country [1] 258135 0
Date submitted for ethics approval [1] 258135 0
15/10/2009
Approval date [1] 258135 0
Ethics approval number [1] 258135 0

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

Contacts
Principal investigator
Name 30518 0
Address 30518 0
Country 30518 0
Phone 30518 0
Fax 30518 0
Email 30518 0
Contact person for public queries
Name 13765 0
Dr Gordon Doig
Address 13765 0
Royal North Shore (RNSH) Intensive Care Unit (ICU), Pacific Highway St Leonards, NSW 2065.
Country 13765 0
Australia
Phone 13765 0
+61 2 99268656
Fax 13765 0
Email 13765 0
[email protected]
Contact person for scientific queries
Name 4693 0
Dr Gordon Doig
Address 4693 0
Royal North Shore (RNSH) Intensive Care Unit (ICU), Pacific Highway St Leonards, NSW 2065.
Country 4693 0
Australia
Phone 4693 0
+61 2 99268656
Fax 4693 0
Email 4693 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIntravenous amino acid therapy for kidney function in critically ill patients: a randomized controlled trial.2015https://dx.doi.org/10.1007/s00134-015-3827-9
N.B. These documents automatically identified may not have been verified by the study sponsor.