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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
Scientific title
A Descriptive Study of Serum Neutrophil Gelatinase-Associated Lipocalin in Patients Undergoing Cardiopulmonary Bypass
Secondary ID [1] 262931 0
Nil
Universal Trial Number (UTN)
U1111-1124-0596
Trial acronym
The NGAL study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Surgery associated Acute kidney injury 270662 0
Condition category
Condition code
Renal and Urogenital 270837 270837 0 0
Kidney disease
Cardiovascular 270883 270883 0 0
Other cardiovascular diseases
Surgery 270884 270884 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 269283 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279519 0
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
Timepoint [1] 279519 0
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.
Secondary outcome [1] 287804 0
AKI using RIFLE classification
Timepoint [1] 287804 0
first 48 hours post CPB
Secondary outcome [2] 287805 0
serum creatinine increase
Timepoint [2] 287805 0
first 5 days post CPB
Secondary outcome [3] 287806 0
requirement for renal replacement therapy i.e. continuous renal replacement therapy or intermittent haemodialysis
Timepoint [3] 287806 0
during hospital stay
Secondary outcome [4] 287807 0
length of mechanical ventilation
Timepoint [4] 287807 0
during hospital stay
Secondary outcome [5] 287808 0
length of ICU stay
Timepoint [5] 287808 0
during hospital stay
Secondary outcome [6] 287809 0
length of hospital stay
Timepoint [6] 287809 0
during hospital stay

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3818 0
New Zealand
State/province [1] 3818 0

Funding & Sponsors
Funding source category [1] 269745 0
Self funded/Unfunded
Name [1] 269745 0
Address [1] 269745 0
Country [1] 269745 0
Primary sponsor type
Individual
Name
Rachael Parke
Address
Cardiothoracic and vascular Intensive Care Unit
Auckland City Hospital
Private Bag 92024
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 268785 0
None
Name [1] 268785 0
Address [1] 268785 0
Country [1] 268785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271708 0
Northern X Regional Ethics Committee
Ethics committee address [1] 271708 0
3rd floor, Unisys building
650 Great South Rd
Penrose
Auckland 1061
Ethics committee country [1] 271708 0
New Zealand
Date submitted for ethics approval [1] 271708 0
30/08/2011
Approval date [1] 271708 0
Ethics approval number [1] 271708 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33082 0
Address 33082 0
Country 33082 0
Phone 33082 0
Fax 33082 0
Email 33082 0
Contact person for public queries
Name 16329 0
Rachael Parke
Address 16329 0
Cardiothoracic and Vascular Intensive Care Unit
Auckland City Hospital
Private Bag 92024
Auckland 1023
Country 16329 0
New Zealand
Phone 16329 0
+6493074949 ext 24489
Fax 16329 0
+6493074906
Email 16329 0
rparke@adhb.govt.nz
Contact person for scientific queries
Name 7257 0
Dr Shay McGuinness
Address 7257 0
Cardiothoracic and Vascular Intensive Care Unit
Auckland City Hospital
Private Bag 92024
Auckland 1023
Country 7257 0
New Zealand
Phone 7257 0
+6493074949 ext 24489
Fax 7257 0
+6493074906
Email 7257 0
shaymc@adhb.govt.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary