Neutrophil Gelatinase-Associated Lipocalin: Biomarker of Acute Kidney Injury After Cardiac Surgery
NCT ID: NCT00594919
Last Updated: 2009-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2007-10-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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AKI group
Acute kidney injury group after cardiac surgery.
No interventions assigned to this group
NKF group
Normal kidney function group after cardiac surgery
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* In need of cardiopulmonary bypass and with the prospect of minimum hospital length stay of 48 hours in ICU
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
Hospital de Base
OTHER
Responsible Party
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FAPESP
Principal Investigators
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Emerson quintino
Role: STUDY_DIRECTOR
Hospital de Base
Locations
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Hospital de Base - São José do Rio preto Medical School
São José do Rio Preto, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1411 - 2007.
Identifier Type: -
Identifier Source: secondary_id
CAAE 0246.0.000.140-07
Identifier Type: -
Identifier Source: org_study_id
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