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

Completed

• Conditions: Patients Undergoing Surgery for Congenital Heart Disease
• Interventions: Procedure: surgery for congenital heart disease

• Registration Number: NCT02081235
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-07
• Study Start: 2014-06
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients who underwent surgery for congenital heart disease	surgery for congenital heart disease	patients who underwent surgery for congenital heart disease during 2012 in Samsung Medical Center

Primary Outcome Measures

Name	Time	Method
Acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global outcome) criteria	during seven days after surgery	Acute kidney injury as defined by KDIGO criteria (Stage 1, 2, 3)

Secondary Outcome Measures

Name	Time	Method
Acute kidney injury as defined by AKIN (acute kidney injury network) criteria	within 48 hours after surgery	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	acute kidney injury diagnosis defined by RIFLE criteria (for Risk, Injury, Failure during seven days after surgery

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of