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Trial registered on ANZCTR
Registration number
ACTRN12611000949987
Ethics application status
Approved
Date submitted
28/08/2011
Date registered
5/09/2011
Date last updated
20/04/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
A Study of changes in a kidney injury biomarker in patients undergoing heart surgery
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Scientific title
A Descriptive Study of Serum Neutrophil Gelatinase-Associated Lipocalin in Patients Undergoing Cardiopulmonary Bypass
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Secondary ID [1]
262931
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Nil
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Universal Trial Number (UTN)
U1111-1124-0596
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Trial acronym
The NGAL study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiac Surgery associated Acute kidney injury
270662
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Condition category
Condition code
Renal and Urogenital
270837
270837
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0
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Kidney disease
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Cardiovascular
270883
270883
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0
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Other cardiovascular diseases
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Surgery
270884
270884
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0
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Serum NGAL will be measured at baseline and then hourly following initiation of cardiopulmonary bypass for twelve hours, two hourly for six hours, and then at 24 and 48 hours post cardiopulmonary bypass.
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Intervention code [1]
269283
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Not applicable
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Comparator / control treatment
Not applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To measure serum NGAL levels in a patient population undergoing cardiopulmonary bypass, who have at least one risk factor for development of AKI. This will be assessed using serum NGAL ELISA
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Assessment method [1]
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Timepoint [1]
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Serum NGAL will be measured at baseline and then hourly following initiation of CPB for twelve hours, two hourly for six hours, and then at 24 and 48 hours post CPB.
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Secondary outcome [1]
287804
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AKI using RIFLE classification
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Assessment method [1]
287804
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Timepoint [1]
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first 48 hours post CPB
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Secondary outcome [2]
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serum creatinine increase
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Assessment method [2]
287805
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Timepoint [2]
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first 5 days post CPB
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Secondary outcome [3]
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requirement for renal replacement therapy i.e. continuous renal replacement therapy or intermittent haemodialysis
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Assessment method [3]
287806
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Timepoint [3]
287806
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during hospital stay
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Secondary outcome [4]
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length of mechanical ventilation
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Assessment method [4]
287807
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Timepoint [4]
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during hospital stay
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Secondary outcome [5]
287808
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length of ICU stay
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Assessment method [5]
287808
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Timepoint [5]
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during hospital stay
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Secondary outcome [6]
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length of hospital stay
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Assessment method [6]
287809
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Timepoint [6]
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during hospital stay
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Eligibility
Key inclusion criteria
Cardiac surgery patients in whom the use of cardiopulmonary bypass is planned and having one or more of the following risk factors for post operative kidney injury:
*Age above 70 years
*New York Heart Association class III/IV or impaired left ventricular function (left ventricular ejection fraction < 50%)
*Valvular surgery or concomitant valvular and coronary artery bypass graft surgery
*Redo cardiac surgery
*Insulin dependent diabetes mellitus.
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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
*Age < 18 years
*Pre-existing renal impairment (preoperative plasma creatinine concentration > 1.4mg/dL)
*Preoperative insertion of an Intra Aortic Balloon Pump (IABP)
*Emergency cardiac surgery
*Planned off-pump cardiac surgery
*Known blood borne infectious disease
*Chronic inflammatory disease on immunosuppression
*Chronic moderate to high dose corticosteroid therapy (>10mg/day prednisone or equivalent)
*Enrolled in a conflicting research study
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/10/2011
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Actual
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Date of last participant enrolment
Anticipated
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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
50
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
3818
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
269745
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Country [1]
269745
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Primary sponsor type
Individual
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Name
Rachael Parke
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Address
Cardiothoracic and vascular Intensive Care Unit
Auckland City Hospital
Private Bag 92024
Auckland 1023
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
268785
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Address [1]
268785
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Country [1]
268785
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern X Regional Ethics Committee
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Ethics committee address [1]
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3rd floor, Unisys building
650 Great South Rd
Penrose
Auckland 1061
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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30/08/2011
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Approval date [1]
271708
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Ethics approval number [1]
271708
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Summary
Brief summary
Injury to the kidney with loss of function is common after cardiac surgery especially in patients with previous kidney disease, old age, diabetes and the need for complex open heart surgery. The development of cardiac surgery associated acute kidney injury (CSA-AKI) is associated with increased length of ICU and hospital stay and increased risk of death. The development of the novel biomarker Neutrophil Gelatinase-Associated Lipocalin (NGAL) has proven to be an effective method for early detection of acute kidney injury (AKI). Early detection of AKI may facilitate early treatment, and may result in improved outcomes for patients with AKI. Standardisation of NGAL measurement has improved the reliability of serum NGAL as a marker of AKI. However the optimal timing for measurement of serum NGAL has yet to be fully elucidated, with different studies measuring NGAL at different time points. Accordingly we propose to study a group of 25 patients undergoing cardiopulmonary bypass, aiming to determine the optimal point or points at which to measure serum NGAL.
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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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Address
33082
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Country
33082
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Phone
33082
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Fax
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Email
33082
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Contact person for public queries
Name
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Rachael Parke
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Address
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Cardiothoracic and Vascular Intensive Care Unit
Auckland City Hospital
Private Bag 92024
Auckland 1023
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Country
16329
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New Zealand
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Phone
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+6493074949 ext 24489
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Fax
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+6493074906
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Shay McGuinness
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Address
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Cardiothoracic and Vascular Intensive Care Unit
Auckland City Hospital
Private Bag 92024
Auckland 1023
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Country
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New Zealand
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Phone
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+6493074949 ext 24489
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Fax
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+6493074906
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Email
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[email protected]
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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
No additional documents have been identified.
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