Acute Kidney Injury After Cardiac Surgery Based on KDIGO Criteria

Acute Kidney Injury Clinical Trial

Official title:

Prognostic Value of Acute Kidney Injury After Cardiac Surgery According to Kidney Disease: Improving Global Outcomes Definition and Staging (KDIGO) Criteria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777465
• Other study ID #: CAAE-3436.0.000.140-08
• Status: Completed
• Phase: N/A
• First received: October 21, 2008
• Last updated: May 19, 2014
• Start date: January 2003
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: Hospital de Base
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2804
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
Brazil	Hospital de Base	São José do Rio Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Base

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Kidney Injury after cardiac surgery as a independent predictor of 30-day mortality	To test the hypothesis that the acute kidney injury based on KDIGO criteria after cardiac surgery is a independent predictor of 30-day mortality	30 days	No