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.

Study Overview

• Status: Unknown
• Conditions: Early Acute Kidney Injury

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).

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Rafael C Miranda, Physician; Phone Number: 55 - 17 32015054; Email: rafacmiranda@gmail.com
• Study Contact Backup: Name: Maurício N Machado, Physician; Phone Number: 55 - 17 32164025; Email: maunmac@gmail.com

Study Locations

• Brazil
  • São Paulo
    • São José do Rio Preto, São Paulo, Brazil, 15090000
      • Recruiting
      • Hospital de Base - São José do Rio preto Medical School
      • Contact: Maurício N Machado, Physician; Phone Number: 55 17 32164025; Email: maunmac@gmail.com
      • Principal Investigator: Rafael C Miranda, Physician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
AKI group; Acute kidney injury group after cardiac surgery.
NKF group; Normal kidney function group after cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the urinary excretion of NGAL as a marker of early development of acute kidney injury in patients undergoing cardiac surgery	96 hours

Collaborators and Investigators

• Sponsor: Hospital de Base
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Study Director: Emerson quintino, Hospital de Base

Study record dates

Study Major Dates

• Study Start: October 1, 2007

Study Registration Dates

• First Submitted: January 7, 2008
• First Submitted That Met QC Criteria: January 15, 2008
• First Posted (Estimate): January 16, 2008

Study Record Updates

• Last Update Posted (Estimate): February 4, 2009
• Last Update Submitted That Met QC Criteria: February 3, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: cardiac surgery; acute kidney injury; ngal
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: CAAE 0246.0.000.140-07; 1411 - 2007.