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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12612000596808
Date of registration: 01/06/2012
Prospective Registration: Yes
Primary sponsor: Shum Hoi Ping
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?
Date of first enrolment: 01/12/2012
Target sample size: 155
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12612000596808.aspx
Study type:  Observational
Study design:  Purpose: Screening;Duration: Cross-sectional;Selection: Convenience sample;Timing: Prospective;  
Phase:  Not Applicable
Countries of recruitment
Hong Kong
Contacts
Name: Dr Dr Shum Hoi Ping   
Address:  Department of Intensive Care Pamela Youde Nethersole Eastern Hospital 3 Lok Man Road Chai Wan Hong Kong
Telephone: +852-25956111
Email: shumhp@ha.org.hk
Affiliation: 
Name: Dr Dr Shum Hoi Ping   
Address:  Department of Intensive Care Pamela Youde Nethersole Eastern Hospital 3 Lok Man Road Chai Wan Hong Kong
Telephone: +852-25956111
Email: shumhp@ha.org.hk
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. All emergency and elective post non-cardiac operation patients that required ICU care

2. Expected ICU length of stay >24 hours

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


Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Acute kidney injury;Post non-cardiac operation;
Acute kidney injury
Post non-cardiac operation
Renal and Urogenital - Kidney disease
Surgery - Other surgery
Intervention(s)
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
Primary Outcome(s)
Occurrence of Acute kidney injury, defined based on Risk, Injury, Failure, Loss and End stage (RIFLE) classification[48 hours from ICU admission]
Secondary Outcome(s)
Requirement of renal replacement therapy (needs of hemofiltration/ hemodiafiltration/ hemodialysis/ continuous renal replacement therapy, based on medical records upon ICU discharge)[During ICU stay]
ICU length of stay (based on medical records upon ICU discharge)[Upon ICU discharge]
ICU mortality (based on medical records upon ICU discharge)[Upon ICU discharge]
Secondary ID(s)
None
Source(s) of Monetary Support
Pamela Youde Nethersole Eastern Hospital
Secondary Sponsor(s)
SCIENCE INTERNATIONAL CORPORATION
Ethics review
Status: Approved
Approval date:
Contact:
Hong Kong East Cluster Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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