Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000596808
Ethics application status
Approved
Date submitted
1/06/2012
Date registered
1/06/2012
Date last updated
2/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
To investigate whether the use of blood marker (plasma neutrophil gelatinase-associated lipocalin) can predict the development of subsequent kidney dysfunction in post non-heart surgical patients who are admitted to the intensive care unit
Scientific title
Does plasma neutrophil gelatinase-associated lipocalin predict acute kidney injury in post non-cardiac surgery-patients that require ICU care?
Secondary ID [1] 280597 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute kidney injury 286601 0
Post non-cardiac operation 286602 0
Condition category
Condition code
Renal and Urogenital 286877 286877 0 0
Kidney disease
Surgery 286878 286878 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The major objective of the study was to estimate the diagnostic accuracy of plasma NGAL on predicting subsequent development of acute kidney injury in non-cardiac postoperative patients that required intensive care. Plasma NGAL was taken within 1 hour and at 6th hour of post-operative ICU admission. Patients are observed until discharge from ICU to assess the presence of any acute kidney injury, requirement of renal support, ICU mortality
Intervention code [1] 284989 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287237 0
Occurrence of Acute kidney injury, defined based on Risk, Injury, Failure, Loss and End stage (RIFLE) classification
Timepoint [1] 287237 0
48 hours from ICU admission
Secondary outcome [1] 297700 0
Requirement of renal replacement therapy (needs of hemofiltration/ hemodiafiltration/ hemodialysis/ continuous renal replacement therapy, based on medical records upon ICU discharge)
Timepoint [1] 297700 0
During ICU stay
Secondary outcome [2] 297701 0
ICU length of stay (based on medical records upon ICU discharge)
Timepoint [2] 297701 0
Upon ICU discharge
Secondary outcome [3] 297702 0
ICU mortality (based on medical records upon ICU discharge)
Timepoint [3] 297702 0
Upon ICU discharge

Eligibility
Key inclusion criteria
1. All emergency and elective post non-cardiac operation patients that required ICU care

2. Expected ICU length of stay >24 hours
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with chronic kidney disease stage 5 (Glomerular filtration rate estimated by Modification of Diet in Renal Disease (MDRD) equation of less than 15 ml/min) or those on renal replacement therapy
2. Surgical intervention that included nephrectomy
3. Cannot obtain consent from patients or their relatives

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2012
Actual
1/12/2012
Date of last participant enrolment
Anticipated
Actual
28/02/2014
Date of last data collection
Anticipated
Actual
30/06/2014
Sample size
Target
155
Accrual to date
Final
151
Recruitment outside Australia
Country [1] 4342 0
Hong Kong
State/province [1] 4342 0

Funding & Sponsors
Funding source category [1] 285356 0
Hospital
Name [1] 285356 0
Pamela Youde Nethersole Eastern Hospital
Country [1] 285356 0
Hong Kong
Primary sponsor type
Individual
Name
Shum Hoi Ping
Address
Department of intensive care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan
Country
Hong Kong
Secondary sponsor category [1] 284206 0
Commercial sector/Industry
Name [1] 284206 0
SCIENCE INTERNATIONAL CORPORATION
Address [1] 284206 0
14/F, Gee Tuck Building, 16-20 Bonham Strand East, Sheung Wan
Country [1] 284206 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287370 0
Hong Kong East Cluster Ethics Committee
Ethics committee address [1] 287370 0
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan
Ethics committee country [1] 287370 0
Hong Kong
Date submitted for ethics approval [1] 287370 0
Approval date [1] 287370 0
21/05/2012
Ethics approval number [1] 287370 0
HKEC-2011-091

Summary
Brief summary
In surgical patients, outcome is strictly dependent on the occurrence of postoperative complication. Acute kidney injury (AKI) occurs in around 1% of noncardiac surgical patients and is commonly associated with more serious complications and poorer outcome (1). Serum creatinine is an insensitive marker for acute kidney injury and may not peak until several days after tubular insult (2). Neutrophil gelatinase-associated lipocalin (NGAL) is expressed by neutrophils, various epithelia as well as in the renal tubules (3). It is highly expressed in cells after infections, inflammation, ischemia or neoplastic transformation. Recent studies suggest that measurement of NGAL in patients at risk for cardiac surgery associated AKI can facilitate early diagnosis and implementation of therapeutic adjustment that decrease renal insult (4). However, the data on applications of plasma NGAL on predicting AKI in non-cardiac surgical patients is limited (5).
The major objective of the study was to estimate the diagnostic accuracy of plasma NGAL on predicting subsequent development of AKI in non-cardiac postoperative patients that required intensive care. Additional objectives were to evaluate plasma NGAL as a biomarker for renal replacement therapy (RRT) use, intensive care unit (ICU) mortality and ICU length of stay.

Workflow:
1. Eligible patients should fulfill all the inclusion criteria and without any exclusion criteria
2. Obtain consent from patient directly. For those with impaired consciousness due to underlying illness or use of sedatives, consent should be obtained from their close relatives. Clear explanation of the workflow should be performed with the use of the information sheet.
3. Plasma NGAL was taken within 1 hour and at 6th hour of post-operative ICU admission.
4. Blood samples were processed within 1 hour of collection using point of care test.
5. Primary and secondary outcomes were analysed subsequently based on medical records

Reference:
1. Brienza N, Giglio MT, Marucci M. Preventing acute kidney injury after noncardiac surgery. Curr Opin Crit Care. 2010;16:353-358.
2. Bellomo R, Kellum JA, Ronco C. Defining acute renal failure: physiological principles. Intensive Care Med. 2004;30:33-37.
3. Kjeldsen L, Cowland JB, Borregaard N. Human neutrophil gelatinase-associated lipocalin and homologous proteins in rat and mouse. Biochim Biophys Acta. 2000;1482:272-283.
4. Cruz DN, Ronco C, Katz N. Neutrophil gelatinase-associated lipocalin: a promising biomarker for detecting cardiac surgery-associated acute kidney injury. J Thorac Cardiovasc Surg. 2010;139:1101-1106.
5. Shavit L, Dolgoker I, Ivgi H, Assous M, Slotki I. Neutrophil gelatinase-associated lipocalin as a predictor of complications and mortality in patients undergoing non-cardiac major surgery. Kidney Blood Press Res. 2011;34:116-124.
Trial website
Trial related presentations / publications
HP Shum et al.: Nephrology 20 (2015) 375–382
Public notes

Contacts
Principal investigator
Name 34249 0
Dr Dr Shum Hoi Ping
Address 34249 0
Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan
Hong Kong SAR
Country 34249 0
Hong Kong
Phone 34249 0
+852-25956111
Fax 34249 0
Email 34249 0
[email protected]
Contact person for public queries
Name 17496 0
Dr Dr Shum Hoi Ping
Address 17496 0
Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan
Country 17496 0
Hong Kong
Phone 17496 0
+852-25956111
Fax 17496 0
Email 17496 0
[email protected]
Contact person for scientific queries
Name 8424 0
Dr Dr Shum Hoi Ping
Address 8424 0
Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan
Country 8424 0
Hong Kong
Phone 8424 0
+852-25956111
Fax 8424 0
Email 8424 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
EmbasePredictive value of plasma neutrophil gelatinase-associated lipocalin for acute kidney injury in intensive care unit patients after major non-cardiac surgery.2015https://dx.doi.org/10.1111/nep.12400
N.B. These documents automatically identified may not have been verified by the study sponsor.