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Acute Kidney Injury After Cardiac Surgery Based on KDIGO Criteria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date October 21, 2008
First Posted Date October 22, 2008
Last Update Posted Date May 21, 2014
Study Start Date January 2003
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2013)
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
Original Primary Outcome Measures
 (submitted: October 21, 2008)
To test the hypothesis that patients with acute kidney injury after cardiac surgery have higher 30-day mortality. [ Time Frame: 30 days ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: October 21, 2008)
  • To identify risk factors associated with acute kidney injury after cardiac surgery. [ Time Frame: 30 days ]
  • To compare clinical outcomes in patients with and without acute kidney injury after cardiac surgery [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acute Kidney Injury After Cardiac Surgery Based on KDIGO Criteria
Official Title Prognostic Value of Acute Kidney Injury After Cardiac Surgery According to Kidney Disease: Improving Global Outcomes Definition and Staging (KDIGO) Criteria
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients selected consecutively after cardiac surgery (CABG or CVS) in a setting of postoperative intensive care unit.
Condition Acute Kidney Injury
Intervention Not Provided
Study Groups/Cohorts
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2013)
2804
Original Actual Enrollment
 (submitted: October 21, 2008)
1936
Actual Study Completion Date June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT00777465
Other Study ID Numbers CAAE-3436.0.000.140-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mauricio de Nassau Machado, Hospital de Base
Study Sponsor Hospital de Base
Collaborators Not Provided
Investigators
Study Director: Lilia N Maia, PhD São José do Rio Preto Medical School
PRS Account Hospital de Base
Verification Date May 2014