ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

None

Trial acronym

None

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute kidney injury

Post non-cardiac operation

Condition category

Condition code

Renal and Urogenital

Kidney disease

Surgery

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]

Not applicable

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Occurrence of Acute kidney injury, defined based on Risk, Injury, Failure, Loss and End stage (RIFLE) classification

Timepoint [1]

48 hours from ICU admission

Secondary outcome [1]

Requirement of renal replacement therapy (needs of hemofiltration/ hemodiafiltration/ hemodialysis/ continuous renal replacement therapy, based on medical records upon ICU discharge)

Timepoint [1]

During ICU stay

Secondary outcome [2]

ICU length of stay (based on medical records upon ICU discharge)

Timepoint [2]

Upon ICU discharge

Secondary outcome [3]

ICU mortality (based on medical records upon ICU discharge)

Timepoint [3]

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?

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]

Hong Kong

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Pamela Youde Nethersole Eastern Hospital

Address [1]

3 Lok Man Road, Chai Wan

Country [1]

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]

Commercial sector/Industry

Name [1]

SCIENCE INTERNATIONAL CORPORATION

Address [1]

14/F, Gee Tuck Building, 16-20 Bonham Strand East, Sheung Wan

Country [1]

Hong Kong

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hong Kong East Cluster Ethics Committee

Ethics committee address [1]

Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan

Ethics committee country [1]

Hong Kong

Date submitted for ethics approval [1]

Approval date [1]

21/05/2012

Ethics approval number [1]

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

Dr Dr Shum Hoi Ping

Address

Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan
Hong Kong SAR

Country

Hong Kong

Phone

+852-25956111

Fax

shumhp@ha.org.hk

Contact person for public queries

Name

Dr Shum Hoi Ping

Address

Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan

Country

Hong Kong

Phone

+852-25956111

Fax

shumhp@ha.org.hk

Contact person for scientific queries

Name

Dr Shum Hoi Ping

Address

Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan

Country

Hong Kong

Phone

+852-25956111

Fax

shumhp@ha.org.hk

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

Source	Title	Year of Publication	DOI
Embase	Predictive value of plasma neutrophil gelatinase-associated lipocalin for acute kidney injury in intensive care unit patients after major non-cardiac surgery.	2015	https://dx.doi.org/10.1111/nep.12400

N.B. These documents automatically identified may not have been verified by the study sponsor.

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