Neutrophil Gelatinase Associated Lipocalin as a predictor of acute kidney injury post coronary angiogram

ISRCTN	ISRCTN88709771
DOI	https://doi.org/10.1186/ISRCTN88709771
Secondary identifying numbers	1.1 19/08/2011

Submission date: 26/08/2011
Registration date: 13/03/2012
Last edited: 18/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
In Northern Ireland the rising number of patients with both chronic kidney disease (CKD) and heart disease is explained by many risk factors. These include age, high blood pressure, diabetes and obesity. Around 6000 coronary dye tests are performed each year in Northern Ireland. 20% of patients tested will have CKD and are at high risk of kidney damage due to the harmful dye used (contrast-induced nephropathy - CIN). Contrast dye is toxic to the kidney. Unfortunately there is no alternative to it and the number of patients who develop this complication is set to rise.

Acute kidney injury (AKI) is best avoided; once developed it dramatically increases risk of death, length of hospital stay and healthcare costs. Current tests fail to detect early AKI and there is a need for new markers of kidney damage. Neutrophil gelatinase associated lipocalin (NGAL) has the potential to detect AKI within a few hours of onset; we aim to study it in a high-risk CKD population.

This study aims to find out whether NGAL could be a useful marker of early CIN and see if it can predict severity of CIN, and to see if NGAL could be used to identify those at high risk of CIN.

Who can participate?
Patients at high risk of CIN will be identified prior to cardiac catheterisation at Craigavon Area Hospital between October 2011 and August 2013. All patients over the age of 18 with existing chronic renal failure, as shown by abnormal blood tests before the dye test, will be invited to take part. Men and women will both be invited.

What does the study involve?
A fluid drip will be given to help protect kidney function before the dye test. Blood samples will be collected directly before and after the dye test, and at 2, 4, 6, 24 and 48 hour time-points. Additional blood will be stored for possible future testing.

What are the possible benefits and risks of participating?
New markers to detect AKI early would help to treat patients who develop AKI sooner. If realised, this research has the potential to dramatically increase the safety of coronary dye testing and could greatly benefit patients both in Northern Ireland and further afield. The only risk to patients will be that of serial blood sampling, which may cause minor bleeding, pain or bruising. This will be reduced by using the smallest needle possible. All patients will have the same treatment.

Where is the study run from?
Craigavon Area Hospital (UK).

When is the study starting and how long is it expected to run for?
The study will run from October 2011 to August 2013.

Who is funding the study?
RANDOX laboratories.

Who is the main contact?
Dr Michael Connolly
Research Fellow
Cardiac Research
Craigavon Area Hospital

Contact information

Dr David Mc Eneaney
Scientific

Cardiology Unit
Craigavon Area Hosptial
68 Lurgan Road
Portadown
BT63 5QQ
United Kingdom

Phone	+44 (0)2838 334 444
Email	david.mceneaney@southerntrust.hscni.net

Study information

Study design	Cohort observational study
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Neutrophil Gelatinase Associated Lipocalin (NGAL) as a predictor of acute kidney injury post coronary angiogram: a cohort observational study
Study objectives	Raised levels of NGAL at 4 hours post contrast angiogram will predict acute kidney injury, as evidenced by a rise in creatinine > 25% at 48 hours.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic Renal Disease
Intervention	Samples for serum and urine NGAL, serum cystatin C and serum creatinine will be collected directly pre- and post-contrast angiogram, and at 2, 4, 6, 24 and 48 hr time-points to allow time course analysis post catheterisation. Patients will be followed up at 30 days and 1 year.
Intervention type	Other
Primary outcome measure	Post procedure biomarker elevation diagnostic for acute kidney injury
Secondary outcome measures	Major cardiac adverse events (MACE) at 30 days and one year: 1. Myocardial infarction 2. Stroke 3. Heart failure hospitalisation 4. Death
Overall study start date	15/10/2011
Completion date	03/08/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	300
Key inclusion criteria	1. Age > 18 years 2. Presenting for angiogram with known chronic kidney disease (CKD) [glomerular filtration rate (GFR) < 60mls/min]
Key exclusion criteria	1. Myocardial infarction (MI) or acute coronary syndrome within previous 6 weeks 2. Hospitalisation within previous 6 weeks 3. Decompensated heart failure 4. Inability to give informed consent
Date of first enrolment	15/10/2011
Date of final enrolment	03/08/2013

Locations

Countries of recruitment

Northern Ireland
United Kingdom

Study participating centre

Cardiology Unit

Portadown
BT63 5QQ
United Kingdom

Sponsor information

Randox Laboratories (UK)
Industry

55 Diamond Road
Crumlin
Antrim
BT29 4QY
United Kingdom

Phone	+44 (0)2894 422 413
Email	maryjo.kurth@randox.com
Website	http://www.randox.com/
"ROR"	https://ror.org/04cte7x29

Funders

Funder type

Industry

Randox Laboratories (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2018	18/01/2019	Yes	No

Editorial Notes

18/01/2019: Publication reference added.
24/08/2016: No publications found, verifying study status with principal investigator