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AKIN Criteria After Cardiac Surgery - Clinical Outcomes and 30-Day Mortality
This study has been completed.
First Received: October 21, 2008   No Changes Posted
Sponsored by: Hospital de Base
Information provided by: Hospital de Base
ClinicalTrials.gov Identifier: NCT00777465
  Purpose

The purpose of the study is to evaluate if acute kidney injury based on AKIN criteria is an independent predictor of 30-day mortality after cardiac surgery.


Condition
Kidney Failure

MedlinePlus related topics: Heart Surgery Kidney Failure Surgery
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: AKIN (Acute Kidney Injury Network) Criteria for Acute Kidney Injury After Cardiac Surgery - Risk Factors, Clinical Outcomes and 30-Day Mortality - Prospective Cohort Study

Further study details as provided by Hospital de Base:

Primary Outcome Measures:
  • To test the hypothesis that patients with acute kidney injury after cardiac surgery have higher 30-day mortality. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify risk factors associated with acute kidney injury after cardiac surgery. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • To compare clinical outcomes in patients with and without acute kidney injury after cardiac surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 1936
Study Start Date: January 2003
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
AKI (-)
Patients without acute kidney injury after cardiac surgery
AKI (+)
Patients with acute kidney injury after cardiac surgery

Detailed Description:

One thousand, nine hundred and thirty-six patients will be enrolled in this series and divided into to groups: Group AKI (-) - patients without acute kidney injury after cardiac surgery. Group AKI (+) - patients with acute kidney injury after cardiac surgery. AKI was defined as an absolute increase in serum creatinine (SCr) of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l) or a percentage increase in SCr of more than or equal to 50% (1.5-fold from baseline). The change in SCr concentration was defined as the difference between immediate postoperative concentration and the highest concentration during the stay in ICU. Risk Factors, Clinical Outcomes and 30-day Mortality will be evaluate in this patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Group AKI (-) and AKI (+) selected consecutively after admission in cardiac surgery postoperative care unit

Criteria

Inclusion Criteria:

  • Patients underwent coronary artery bypass grafting or cardiac valve surgery
  • Patients with at least two serum creatinine values within 48 hours.

Exclusion Criteria:

  • Patients with end-stage kidney disease requiring renal replacement therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00777465

Locations
Brazil, São Paulo
Hospital de Base
São José do Rio Preto, São Paulo, Brazil, 15090-000
Sponsors and Collaborators
Hospital de Base
Investigators
Study Director: Lilia N Maia, PhD São José do Rio Preto Medical School
  More Information

No publications provided

Responsible Party: São José do Rio Preto Medical School ( Mauricio N Machado )
Study ID Numbers: CAAE-3436.0.000.140-08
Study First Received: October 21, 2008
Last Updated: October 21, 2008
ClinicalTrials.gov Identifier: NCT00777465     History of Changes
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Base:
Kidney failure
Risk factors
Clinical outcomes
Coronary artery bypass
Cardiac valve surgery
Coronary artery bypass grafting
Cardiac valve surgery
Morbidity
Mortality

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:
Renal Insufficiency
Urologic Diseases
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on May 06, 2009