Neutrophil Gelatinase-Associated Lipocalin: Biomarker of Acute Kidney Injury After Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT00594919|
Recruitment Status : Unknown
Verified February 2009 by Hospital de Base.
Recruitment status was: Recruiting
First Posted : January 16, 2008
Last Update Posted : February 4, 2009
|Condition or disease|
|Early Acute Kidney Injury|
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).
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Neutrophil Gelatinase-Associated Lipocalin(NGAL): Early Biomarker of Acute Kidney Injury After Cardiac Surgery|
|Study Start Date :||October 2007|
Acute kidney injury group after cardiac surgery.
Normal kidney function group after cardiac surgery
- Evaluate the urinary excretion of NGAL as a marker of early development of acute kidney injury in patients undergoing cardiac surgery [ Time Frame: 96 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594919
|Contact: Rafael C Miranda, Physician||55 - 17 email@example.com|
|Contact: Maurício N Machado, Physician||55 - 17 firstname.lastname@example.org|
|Hospital de Base - São José do Rio preto Medical School||Recruiting|
|São José do Rio Preto, São Paulo, Brazil, 15090000|
|Contact: Maurício N Machado, Physician 55 17 32164025 email@example.com|
|Principal Investigator: Rafael C Miranda, Physician|
|Study Director:||Emerson quintino||Hospital de Base|