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Status unknownNCT03266367Updated Sep 5, 2017

Neutrophil Gelatinase Associated Liocalin in Predicting AKI in Coronary Artery Disease

An observational study in Acute Kidney Injury, sponsored by Assiut University. Status unknown. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-05.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
45
Ages
20 Years to 70 Years
Sex
All
01

Study summary

The aim of this work is to assess the clinical significance of serum levels of neutrophil gelatinase-associated lipocalin (NGAL) to predict AKI in patients exposed to PCI.

Read the detailed description

ST-elevated myocardial infarction(STEMI) patients are at a particularly high risk of acute kidney injury (AKI) because of the complexity of hemodynamic disorders and adverse effects associated with the use of radiopaque diagnostic and treatment methods (Smirnov AV.et al.,2009) With wide application of percutaneous coronary intervention (PCI) technology in patients with coronary artery disease (CAD), contrast-induced acute kidney injury (CI-AKI) has become a serious complication and is the third leading cause of AKI in hospitalized patients.(Gleeson.et al. 2004)

To date,AKI diagnosis has been limited to observation of increasing levels of serum creatinine,decrease in urine output,and alterations in urinary chemistry (Bellomo.et al.2004;Mehta.et al. 2007) Nevertheless,serum creatinine levels do not increase significantly until renal function has decreased to 50% in addition,the level of serum creatinine may be affected by the patient's muscle mass,catabolic state,protein intake,weight,sex and tubular secretion of creatinine.Therefore,applying serum creatinine as a biomarker for diagnosing AKI may result in the loss of valuable time (Mishra.et al.2005;Sirota.et al.2011)

Neutrophil Gelatinase-associated lipocalin(NGAL) belongs to the lipocalin family and is produced predominantly by the liver and white blood cells(Hvidberg.et al.,2005).

A small polypeptide, neutrophil gelatinase-associated lipocalin (NGAL), is one of the most promising and best-studied AKI biomarkers (Mishra.et al.,2003; Devarajan.et al 2003) The expression of NGAL was predominantly in proliferating and regenerating tubular epithelial cells, which suggested a role in repair. (Mori.et al.2005) The majority of NGAL, secreted by injured renal tubule epithelial cells, is in a 25kDa monomeric form. In contrast, neutrophils have been claimed to release NGAL primarily as a 45kDa homodimer, i.e. two NGAL monomers linked by a disulfide bridge. It also exists as a 135-kDa heterodimer, covalently conjugated with gelatinase (Cai.et al.2010) NGAL is easily detected in blood and urine due to its small size and resistance to degradation. It can be measured non-invasively using routine laboratory analysers as well as some point of care devices. Furthermore, NGAL concentration in both urine and plasma rises rapidly in a dose-dependent manner that is proportional to the degree of acute kidney damage (Haase-Fielitz.et al.2009)

NGAL has previously been termed the 'troponin-like' biomarker to detect subclinical AKI even in the absence of diagnostic increases in SCr (Devarajan.,2010;Haase,et al.2011) Additionally, NGAL has been reported to be predictive 48 h prior to the actual time of injury; therefore, renal replacement therapy can be planned earlier(Cruz,et al.2010)

02

Conditions studied

03

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

all male and female patients with coronary artery disease who are recently exposed to PCI (20_70 years old )

Inclusion criteria

  • patients exposed to percutaneous coronary intervention

Exclusion criteria

Exclusion Criteria:

  • 1.Diabetes mellitus 2.Liver disease 3.Chronic Kidney Disease 4.Renal Replacement Therapy 5.Previous kidney transplant 6.Chronic infection
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
45 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients

    NGAL and renal functions will be measured two hours after Percutaneous coronary intervention and two days later as a follow up

    Diagnostic Test: Neutrophil gelatinase-associated lipocalin (NAGL)

  • Healthy Group

    control group

    Diagnostic Test: Neutrophil gelatinase-associated lipocalin (NAGL)

Interventions

  • Diagnostic testNeutrophil gelatinase-associated lipocalin (NAGL)

    Serum level of Neutrophil gelatinase-associated lipocalin (NAGL) using the enzyme linked immunosorbent assay kits (ELISA)

05

What researchers measure

Primary outcomes

  1. The rise of NGAL in AKI after PCI before rise of renal function

    Time frame: 2 days

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24. PubMed 15312219 ↗
  • Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713. PubMed 17331245 ↗
  • Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8. doi: 10.1016/S0140-6736(05)74811-X. PubMed 15811456 ↗
  • Hvidberg V, Jacobsen C, Strong RK, Cowland JB, Moestrup SK, Borregaard N. The endocytic receptor megalin binds the iron transporting neutrophil-gelatinase-associated lipocalin with high affinity and mediates its cellular uptake. FEBS Lett. 2005 Jan 31;579(3):773-7. doi: 10.1016/j.febslet.2004.12.031. PubMed 15670845 ↗
  • Mishra J, Ma Q, Prada A, Mitsnefes M, Zahedi K, Yang J, Barasch J, Devarajan P. Identification of neutrophil gelatinase-associated lipocalin as a novel early urinary biomarker for ischemic renal injury. J Am Soc Nephrol. 2003 Oct;14(10):2534-43. doi: 10.1097/01.asn.0000088027.54400.c6. PubMed 14514731 ↗
  • Devarajan P, Mishra J, Supavekin S, Patterson LT, Steven Potter S. Gene expression in early ischemic renal injury: clues towards pathogenesis, biomarker discovery, and novel therapeutics. Mol Genet Metab. 2003 Dec;80(4):365-76. doi: 10.1016/j.ymgme.2003.09.012. PubMed 14654349 ↗
  • Mori K, Lee HT, Rapoport D, Drexler IR, Foster K, Yang J, Schmidt-Ott KM, Chen X, Li JY, Weiss S, Mishra J, Cheema FH, Markowitz G, Suganami T, Sawai K, Mukoyama M, Kunis C, D'Agati V, Devarajan P, Barasch J. Endocytic delivery of lipocalin-siderophore-iron complex rescues the kidney from ischemia-reperfusion injury. J Clin Invest. 2005 Mar;115(3):610-21. doi: 10.1172/JCI23056. PubMed 15711640 ↗
  • Cai L, Rubin J, Han W, Venge P, Xu S. The origin of multiple molecular forms in urine of HNL/NGAL. Clin J Am Soc Nephrol. 2010 Dec;5(12):2229-35. doi: 10.2215/CJN.00980110. Epub 2010 Sep 9. PubMed 20829422 ↗
  • Haase-Fielitz A, Bellomo R, Devarajan P, Bennett M, Story D, Matalanis G, Frei U, Dragun D, Haase M. The predictive performance of plasma neutrophil gelatinase-associated lipocalin (NGAL) increases with grade of acute kidney injury. Nephrol Dial Transplant. 2009 Nov;24(11):3349-54. doi: 10.1093/ndt/gfp234. Epub 2009 May 27. PubMed 19474273 ↗
  • Haase M, Devarajan P, Haase-Fielitz A, Bellomo R, Cruz DN, Wagener G, Krawczeski CD, Koyner JL, Murray P, Zappitelli M, Goldstein SL, Makris K, Ronco C, Martensson J, Martling CR, Venge P, Siew E, Ware LB, Ikizler TA, Mertens PR. The outcome of neutrophil gelatinase-associated lipocalin-positive subclinical acute kidney injury: a multicenter pooled analysis of prospective studies. J Am Coll Cardiol. 2011 Apr 26;57(17):1752-61. doi: 10.1016/j.jacc.2010.11.051. PubMed 21511111 ↗
  • Cruz DN, de Cal M, Garzotto F, Perazella MA, Lentini P, Corradi V, Piccinni P, Ronco C. Plasma neutrophil gelatinase-associated lipocalin is an early biomarker for acute kidney injury in an adult ICU population. Intensive Care Med. 2010 Mar;36(3):444-51. doi: 10.1007/s00134-009-1711-1. Epub 2009 Dec 3. PubMed 19956925 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03266367
Lead sponsor
Assiut University
Responsible party
Bassant Rashad (Resident Doctor, Assiut University) — Principal investigator
First posted
Aug 30, 2017
Start date
Sep 15, 2017 (estimated)
Primary completion
Dec 1, 2018 (estimated)
Completion
Sep 15, 2019 (estimated)
Last update
Sep 5, 2017

Study contacts

Basant R Mohamed, Dr
Contact
touch_my_heart12345@yahoo.com
01008669457
Zeinab A Abdelhamed
Contact
zeinabdoctor@yahoo.com
01003233267

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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