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

Early Acute Kidney Injury Clinical Trial

Official title:

Neutrophil Gelatinase-Associated Lipocalin(NGAL): Early Biomarker of Acute Kidney Injury After Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00594919
• Other study ID #: CAAE 0246.0.000.140-07
• Secondary ID: 1411 - 2007.
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2008
• Last updated: February 3, 2009
• Start date: October 2007

Study information

• Verified date: February 2009
• Source: Hospital de Base
• Contact: Rafael C Miranda, Physician
• Phone: 55 - 17 32015054
• Email: rafacmiranda[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Early Acute Kidney Injury

Locations

Country	Name	City	State
Brazil	Hospital de Base - São José do Rio preto Medical School	São José do Rio Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Base	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the urinary excretion of NGAL as a marker of early development of acute kidney injury in patients undergoing cardiac surgery		96 hours	No