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

NCT ID: NCT00594919

Last Updated: 2009-02-04

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Brief Summary

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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

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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).

Conditions

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Early Acute Kidney Injury

Study Design

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Study Time Perspective

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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Hospital de Base

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rafael C Miranda, Physician

Role: CONTACT

55 - 17 32015054

Maurício N Machado, Physician

Role: CONTACT

55 - 17 32164025

Facility Contacts

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Maurício N Machado, Physician

Role: primary

55 17 32164025

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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