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Neutrophil Gelatinase-Associated Lipocalin: Biomarker of Acute Kidney Injury After Cardiac Surgery

Neutrophil Gelatinase-Associated Lipocalin(NGAL): Early Biomarker of Acute Kidney Injury After Cardiac Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00594919
Enrollment
150
Registered
2008-01-16
Start date
2007-10-31
Completion date
Unknown
Last updated
2009-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Acute Kidney Injury

Keywords

acute kidney injury, ngal, cardiac surgery

Brief summary

The following objectives were used for comparison: 1)primary objective: Evaluate the urinary excretion of NGAL as a marker of early development of acute kidney injury in patients undergoing cardiac surgery.

Detailed description

All patients aged greater than 18 years undergoing elective cardiac surgery for coronary artery bypass grafting and / or valve replacement, in need of cardiopulmonary bypass and with the prospect of minimum hospital length stay of 48 hours in ICU, will be candidates for participation in this study. Criteria for exclusion Patients with IRA before hospitalization in the ICU; Patients with estimated glomerular filtration (MDRD formula simplified) less than 30 ml / min; Patients transplanted kidney; Patients with chronic renal failure on dialysis; Patients anuric the admission in the ICU; Refusal to participate in the study. Definition of IRA: IRA will be defined according to the new proposal of AKIN (Acute Kidney Injury Network) (awaiting publication): abrupt elevation (48 hours) of serum creatinine in value greater than or equal to 0.3 mg / dL or an increase of 50% compared to baseline or reduction of urinary volume to 0.5 ml / kg / h for more than 6 hours (Annex 1). Laboratory Investigations Samples of urine will be collected before surgery, after 2, 4, 6, 12, 24, 48, 72 and 96 hours after the end of the CEC for determination of creatinine and urinary NGAL (normalization of NGAL for excretion urinary creatinine). The serum creatinine is measured before surgery and daily during the first 4 days after surgery for the diagnosis of IRA. If the time of CEC exceed 2 hours, the first sample of urine after the end of the CEC will be considered as sample 2 hours. Quantification of NGAL Samples of urine will be centrifuged (5 min at 2000 rpm) and frozen at -20 ° C for later determination of NGAL by method of ELISA (Kit commercial AntybodyShop, Denmark).

Interventions

None listed

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Hospital de Base
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged greater than 18 years undergoing elective cardiac surgery for coronary artery bypass grafting and/or valve replacement * In need of cardiopulmonary bypass and with the prospect of minimum hospital length stay of 48 hours in ICU

Exclusion criteria

* Patients with IRA before hospitalization in the ICU * Patients with estimated glomerular filtration (MDRD formula simplified) less than 30 ml/min * Patients transplanted kidney * Patients with chronic renal failure on dialysis * Patients anuric the admission in the ICU * Refusal to participate in the study. Definition of IRA: IRA will be defined according to the new proposal of AKIN (Acute Kidney Injury Network) (awaiting publication): abrupt elevation (48 hours) of serum creatinine in value greater than or equal to 0.3 mg / dL or an increase of 50% compared to baseline or reduction of urinary volume to 0.5 ml / kg / h for more than 6 hours

Design outcomes

Primary

MeasureTime frame
Evaluate the urinary excretion of NGAL as a marker of early development of acute kidney injury in patients undergoing cardiac surgery96 hours

Countries

Brazil

Contacts

Primary ContactRafael C Miranda, Physician
rafacmiranda@gmail.com55 - 17 32015054
Backup ContactMaurício N Machado, Physician
maunmac@gmail.com55 - 17 32164025

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026