AKIN Criteria After Cardiac Surgery - Clinical Outcomes and 30-Day Mortality - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 21, 2008

Last Updated Date

October 21, 2008

Start Date ^†

January 2003

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

AKIN Criteria After Cardiac Surgery - Clinical Outcomes and 30-Day Mortality

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

Brief Summary

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.

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.

Study Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Condition ^†

Kidney Failure

Intervention ^†

Study Arms / Comparison Groups

Patients without acute kidney injury after cardiac surgery
Patients with acute kidney injury after cardiac surgery

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

1936

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Brazil

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00777465

Responsible Party

Mauricio N Machado, São José do Rio Preto Medical School

Secondary IDs ^††

Study Sponsor ^†

Hospital de Base

Collaborators ^††

Investigators ^†

Study Director:

Lilia N Maia, PhD

São José do Rio Preto Medical School

Information Provided By

Hospital de Base

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.