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AKIN Criteria: Acute Kidney Injury After On-Pump Coronary Artery Bypass Graft (CABG)

This study has been completed.
Sponsor:
Information provided by:
Hospital de Base
ClinicalTrials.gov Identifier:
NCT00780845
First received: October 27, 2008
Last updated: November 3, 2008
Last verified: October 2008
History of Changes
  Purpose

The purpose of this study is evaluate clinical outcomes and 30-day mortality after on-pump CABG.


Condition
Kidney Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: AKIN (Acute Kidney Injury Network): Acute Kidney Injury After On-Pump Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Base:

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

Secondary Outcome Measures:
  • To compare clinical outcomes in patients with and without acute kidney injury after on-pump CABG [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 817
Study Start Date: January 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
AKI (-)
Patients without acute kidney injury after on-pump CABG
AKI (+)
Patients with acute kidney injury after on-pump CABG

Detailed Description:

Eight hundred and seventeen patients was enrolled in this series and divided into to groups: Group AKI (-) - patients without acute kidney injury after on-pump CABG. Group AKI (+) - patients with acute kidney injury after on-pump CABG. 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. Clinical Outcomes and 30-day mortality was 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

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

Criteria

Inclusion Criteria:

  • Patients underwent on-pump coronary artery bypass grafting
  • 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: NCT00780845

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 by Hospital de Base

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mauricio N Machado, São José do Rio Preto Medical School
ClinicalTrials.gov Identifier: NCT00780845     History of Changes
Other Study ID Numbers: CAAE-3438.0.000.140-08
Study First Received: October 27, 2008
Last Updated: November 3, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Base:
Acute Kidney failure
Clinical outcomes
On-pump
 Coronary artery bypass grafting
Morbidity
Mortality

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

ClinicalTrials.gov processed this record on May 23, 2013