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Acute Kidney Injury After Cardiac Surgery Based on KDIGO Criteria

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ClinicalTrials.gov Identifier: NCT00777465
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
Mauricio de Nassau Machado, Hospital de Base

Study Description
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Brief Summary:
The aim of this study was to apply the acute kidney injury criteria based on KDIGO classification in a population of patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) or cardiac valve surgery (CVS)] and evaluate its impact as a predictor of 30-day mortality.

Condition or disease
Acute Kidney Injury

Detailed Description:
This was a single center study. We evaluated retrospectively patients from the Cardiac Surgery Intensive Care Unit in Hospital de Base, São José do Rio Preto Medical School, São Paulo, Brazil. Demographics, type of surgery, laboratory data and preoperative, perioperative, and postoperative information were retrieved from a prospectively collected database of 2878 patients older than 18 years undergoing isolated CABG (1786) or CVS (1092), from January 2003 to June 2013. After applying the exclusion criteria (51 patients with incomplete data and 23 patients with end-stage kidney disease) we analyzed 2804 patients in total, 1738 (62%) underwent CABG and 1066 (38%) underwent CVS.
Study Design
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Study Type : Observational
Actual Enrollment : 2804 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of Acute Kidney Injury After Cardiac Surgery According to Kidney Disease: Improving Global Outcomes Definition and Staging (KDIGO) Criteria
Study Start Date : January 2003
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Groups and Cohorts
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Group/Cohort
KDIGO 0
Patients with no acute kidney injury after cardiac surgery
KDIGO 1
Patients with acute kidney injury KDIGO stage 1 after cardiac surgery (Increase in SCr by ≥ 0.3 mg/dL (≥ 26.5 lmol/L) or 1.5 to 1.9 times baseline)
KDIGO 2
Patients with acute kidney injury KDIGO stage 2 after cardiac surgery (2.0 to 2.9 times baseline SCr)
KDIGO 3
Patients with acute kidney injury KDIGO stage 3 after cardiac surgery (3.0 times baseline or more; or increase in SCr to ≥ 4.0 mg/dL; or initiation of renal replacement therapy)


Outcome Measures
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Primary Outcome Measures :
  1. Acute Kidney Injury after cardiac surgery as a independent predictor of 30-day mortality [ Time Frame: 30 days ]
    To test the hypothesis that the acute kidney injury based on KDIGO criteria after cardiac surgery is a independent predictor of 30-day mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients selected consecutively after cardiac surgery (CABG or CVS) in a setting of postoperative intensive care unit.
Criteria

Inclusion Criteria:

patients undergoing isolated coronary artery bypass grafting or cardiac valve surgery.

Exclusion Criteria:

patients with incomplete data and patients with end-stage kidney disease.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777465


Locations
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Brazil
Hospital de Base
São José do Rio Preto, São Paulo, Brazil, 15090-000
Sponsors and Collaborators
Hospital de Base
Investigators
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Study Director: Lilia N Maia, PhD São José do Rio Preto Medical School
More Information
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Responsible Party: Mauricio de Nassau Machado, Cardiologist in-chief - Coronary Care Unit, Hospital de Base
ClinicalTrials.gov Identifier: NCT00777465    
Other Study ID Numbers: CAAE-3436.0.000.140-08
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014
Keywords provided by Mauricio de Nassau Machado, Hospital de Base:
Acute kidney injury
Kidney failure
Risk factors
Clinical outcomes
 Cardiac valve surgery
Coronary artery bypass grafting
Morbidity
Mortality
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases