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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Hospital de Base.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Hospital de Base
ClinicalTrials.gov Identifier:
NCT00594919
First received: January 7, 2008
Last updated: February 3, 2009
Last verified: February 2009

January 7, 2008
February 3, 2009
October 2007
Not Provided
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00594919 on ClinicalTrials.gov Archive Site
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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

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.

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).

Observational
Time Perspective: Prospective
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Non-Probability Sample

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.

Early Acute Kidney Injury
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  • AKI group
    Acute kidney injury group after cardiac surgery.
  • NKF group
    Normal kidney function group after cardiac surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
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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

Both
18 Years and older
No
Contact: Rafael C Miranda, Physician 55 - 17 32015054 rafacmiranda@gmail.com
Contact: Maurício N Machado, Physician 55 - 17 32164025 maunmac@gmail.com
Brazil
 
NCT00594919
CAAE 0246.0.000.140-07, 1411 - 2007.
No
Fundação de Amparo à Pesquisa do Estado de São Paulo, FAPESP
Hospital de Base
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study Director: Emerson quintino Faculdade de Medicina de São José do Rio preto - Hospital de Base
Hospital de Base
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP