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Clinical Trials/NCT02081235
NCT02081235
Completed
Not Applicable

Incidence, Risk Factors, and Risk Model of Acute Kidney Injury in Pediatric Patients Who Undergoing Surgery for Congenital Heart Disease

Samsung Medical Center1 site in 1 country220 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients Undergoing Surgery for Congenital Heart Disease
Sponsor
Samsung Medical Center
Enrollment
220
Locations
1
Primary Endpoint
Acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global outcome) criteria
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. Previous studies have reported that the incidence of AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI increase the patient mortality, intensive care unit stay and hospital stay. Previous studies have reported several risk factors for AKI after congenital heart surgery, however, perioperative variables including anesthesia-related factors have not been evaluated fully. Therefore, the investigators attempt to find out independent risk factors regarding perioperative variables.

Detailed Description

Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. Previous studies have reported that the incidence of AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI increase the patient mortality, intensive care unit stay and hospital stay. Previous studies have reported several risk factors for AKI after congenital heart surgery, however, perioperative variables including anesthesia-related factors have not been evaluated fully. In addition, a neutrophil-lymphocyte ratio (NLR), which have been reported to be a marker for systemic inflammation and associated with prognosis of cardiac and cancer patients might be able to predict development of postoperative AKI. Therefore, the investigators attempt to assess independent risk factors regarding perioperative variables including transfusion-related parameters, preoperative anemia, preoperative hypoalbuminemia, pulmonary hypertension, use of nitric oxide, use of hydroxyethyl starch, perioperative medication, hemodynamic variables and perioperative NLR.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
February 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

WonHo Kim

Assistant Professor

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

  • patients who underwent surgery for congenital heart disease between January 2012 and December 2012 in Samsung Medical Center

Exclusion Criteria

  • incomplete data for creatinine, estimated glomerular filtration rate, or urine output required to diagnose acute kidney injury
  • patients who expired within 24 hours after surgery

Outcomes

Primary Outcomes

Acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global outcome) criteria

Time Frame: during seven days after surgery

Acute kidney injury as defined by KDIGO criteria (Stage 1, 2, 3)

Secondary Outcomes

  • Acute kidney injury as defined by AKIN (acute kidney injury network) criteria(within 48 hours after surgery)
  • acute kidney injury diagnosis defined by RIFLE criteria(during seven days after surgery)

Study Sites (1)

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