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

Patients Undergoing Surgery for Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081235
• Other study ID #: 2013-12-101
• Status: Completed
• Phase: N/A
• First received: March 5, 2014
• Last updated: June 14, 2016
• Start date: June 2014
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Heart Defects, Congenital
• Heart Diseases
• Patients Undergoing Surgery for Congenital Heart Disease

Intervention

Procedure:
• surgery for congenital heart disease
surgery for congenital heart disease

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global outcome) criteria	Acute kidney injury as defined by KDIGO criteria (Stage 1, 2, 3)	during seven days after surgery	Yes
Secondary	Acute kidney injury as defined by AKIN (acute kidney injury network) criteria	Acute kidney injury as defined by AKIN (acute kidney injury network) criteria within 48 hours after surgery	within 48 hours after surgery	Yes
Secondary	acute kidney injury diagnosis defined by RIFLE criteria	acute kidney injury diagnosis defined by RIFLE criteria (for Risk, Injury, Failure during seven days after surgery	during seven days after surgery	Yes