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
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
Trial website
Trial related presentations / publications
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 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 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.