Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000134820
Ethics application status
Not yet submitted
Date submitted
27/01/2012
Date registered
31/01/2012
Date last updated
31/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of high-normal dose protein compared to standard-normal dose protein intake after cardiac surgery.
Scientific title
Nephro-protective effects of L-amino acids versus standard care/usual care in cardiac surgery adult patients at risk of developing acute kidney injury. A pilot randomised controlled trial.
Secondary ID [1] 279828 0
None
Universal Trial Number (UTN)
Trial acronym
Cardiac Nephro-Protective Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Bypass Surgery Patients 285667 0
Acute Kidney Injury 285706 0
Condition category
Condition code
Renal and Urogenital 285849 285849 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 that they have a central venous catheter insitu.
Intervention code [1] 284108 0
Treatment: Other
Comparator / control treatment
Standard Care / Usual Care, which encompasses all aspects of standard / usual care delivered post operatively to cardiac bypass surgery patients.
Control group
Active

Outcomes
Primary outcome [1] 286354 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. Qualification of organ failure for clinical trials and clinical practice. Am J Res Crit Care Med 1995;151:A323).
Timepoint [1] 286354 0
Duration of Hospital Stay
Secondary outcome [1] 295653 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] 295653 0
Measured during Hospital Stay
Secondary outcome [2] 295654 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] 295654 0
Measured during Hospital Stay
Secondary outcome [3] 295655 0
Quality of Life assessed using RAND-36.
Timepoint [3] 295655 0
Measured at Day 90 Post randomisation into the trial
Secondary outcome [4] 295656 0
Need for dialysis - i.e. is the patient receiving or scheduled to receive any form of dialysis (continuous haemodyalsis, intermittent peritoneal dialysis etc) at Day 90
Timepoint [4] 295656 0
Measured at Day 90 post randomisation into the trial
Secondary outcome [5] 295657 0
Duration of ICU and Hospital Stay. Assessed by prospectively observing and recording Intensive Care Unit (ICU) and Hospital Stay
Timepoint [5] 295657 0
Measured at Day 90 post randomisation into the trial
Secondary outcome [6] 295658 0
Duration of Mechanical Ventilation. Assessed by prospectively observing and recording Mechanical Ventilation delivered to enrolled patients.
Timepoint [6] 295658 0
Measured during ICU Stay
Secondary outcome [7] 295659 0
Days of antibiotic use. Asessed by prospectively observing and recording Antibiotics delivered to enrolled patients on each day of Hospital Stay.
Timepoint [7] 295659 0
Measured during Hospital Stay

Eligibility
Key inclusion criteria
Patients with pre-existing Chronic Kidney Disease Stage 3 or higher (eGFR <60 ml/min/1.73m2) who are scheduled to undergo on-pump valve replacement or on-pump coronary artery bypass graft surgery expected to require longer than one hour on-pump will be considered eligible. Unless at least one of the Exclusion Criteria listed below is met, these patients will be approached to provide informed consent to participate.
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)Was the actual on-pump surgical time less than 1 hour; 2) The patient does not have a central venous access line through which the study intervention could be delivered; 3) The patient is not able to tolerate at least 1L of fluid volume per day; 4) The patient is currently less than 18 years old; 5) Is the patient receiving NSAID, with specific emphasis on COX-2 inhibitors during their ICU or hospital stay; 6) Is the patient currently enrolled into a clinical trial evaluating a nitric oxide (NO) inhibitor; 7) Is the patient receiving Acetazolamide, which is a diuretic that works on the proximal tubule; 8) Is the patient's current eGFR < 20 ml/min/1.73 m2; 9) Is the patient currently known to have severe Acute Kidney Injury, defined as a Current serum creatinine (SCr) increased 3 times pre-acute illness value OR SCr >350umol/L with recent increase greater than 44 umol/L; 10) Is the patient receiving or scheduled to begin dialysis/renal replacement therapy; 11) Has the patient ever had a kidney transplant; 12) Is the patient expected to receive palliative care only and is not expected to survive ICU or hospital discharge; 13) Is the patient moribund and not expected to survive 24 hrs; 14) Is the patient brain dead or suspected to be brain dead; 15) Has the patient been taking Nardil (phenelzine) within the last 6 weeks; 16) Has the patient previously been enrolled and randomised into this study; 17) Does the patient have a documented contraindication to the study intervention (IV amino acids) as listed on the TGA product licensing document.

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 truly 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
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284568 0
Charities/Societies/Foundations
Name [1] 284568 0
North Shore Heart Research Foundation
Country [1] 284568 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 283488 0
None
Name [1] 283488 0
Address [1] 283488 0
Country [1] 283488 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286555 0
Harbour HREC
Ethics committee address [1] 286555 0
Royal North Shore Hospital
Building 51
Pacific Hwy
St Leonards
NSW 2065
Ethics committee country [1] 286555 0
Australia
Date submitted for ethics approval [1] 286555 0
20/01/2012
Approval date [1] 286555 0
Ethics approval number [1] 286555 0

Summary
Brief summary
The purpose of this research study is to investigate whether a treatment involving the delivery of protein supplements into the vein (intravenous) can protect cardiac bypass surgery patients from the onset of a new kidney injury, when compared with standard treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33675 0
Address 33675 0
Country 33675 0
Phone 33675 0
Fax 33675 0
Email 33675 0
Contact person for public queries
Name 16922 0
A/Prof Gordon Doig
Address 16922 0
Royal North Shore Hospital,
Intensive Care Unit, Level 6,
Pacific Hwy,
St Leonards, NSW, 2065
Country 16922 0
Australia
Phone 16922 0
+61 2 9926 8656
Fax 16922 0
Email 16922 0
[email protected]
Contact person for scientific queries
Name 7850 0
A/Prof Gordon Doig
Address 7850 0
Royal North Shore Hospital,
Intensive Care Unit, Level 6,
Pacific Hwy,
St Leonards, NSW, 2065
Country 7850 0
Australia
Phone 7850 0
+61 2 9926 8656
Fax 7850 0
Email 7850 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 protection in cardiac surgery patients: A pilot randomized controlled trial.2019https://dx.doi.org/10.1016/j.jtcvs.2018.11.097
N.B. These documents automatically identified may not have been verified by the study sponsor.