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
  Purpose

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.


Condition
Early Acute Kidney Injury

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Neutrophil Gelatinase-Associated Lipocalin(NGAL): Early Biomarker of Acute Kidney Injury After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Hospital de Base:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: October 2007
Groups/Cohorts
AKI group
Acute kidney injury group after cardiac surgery.
NKF group
Normal kidney function group after cardiac surgery

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594919

Contacts
Contact: Rafael C Miranda, Physician 55 - 17 32015054 rafacmiranda@gmail.com
Contact: Maurício N Machado, Physician 55 - 17 32164025 maunmac@gmail.com

Locations
Brazil
Hospital de Base - São José do Rio preto Medical School Recruiting
São José do Rio Preto, São Paulo, Brazil, 15090000
Contact: Maurício N Machado, Physician    55 17 32164025    maunmac@gmail.com   
Principal Investigator: Rafael C Miranda, Physician         
Sponsors and Collaborators
Hospital de Base
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Director: Emerson quintino Faculdade de Medicina de São José do Rio preto - Hospital de Base
  More Information

No publications provided

Responsible Party: Fundação de Amparo à Pesquisa do Estado de São Paulo, FAPESP
ClinicalTrials.gov Identifier: NCT00594919     History of Changes
Other Study ID Numbers: CAAE 0246.0.000.140-07, 1411 - 2007.
Study First Received: January 7, 2008
Last Updated: February 3, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Base:
acute kidney injury
ngal
cardiac surgery

Additional relevant MeSH terms:
Acute Kidney Injury
Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014