Clinical trial NCT02081235: Incidence, Risk Factors, and Risk Model of Acute Kidney Injury in Pediatric Patients Who Undergoing Surgery for Congenital Heart Disease
Official title: Incidence, Risk Factors, and Risk Model of Acute Kidney Injury in Pediatric Patients Who Undergoing Surgery for Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Undergoing Surgery for Congenital Heart Disease
Keywords: congenital heart disease
acute kidney injury
risk factor
anesthesia
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 220
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent surgery for congenital heart disease between 2009 and 2013 in 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.

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

Primary outcomes:
measure: Acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global outcome) criteria
timeFrame: during seven days after surgery
Secondary outcomes:
measure: Acute kidney injury as defined by AKIN (acute kidney injury network) criteria
timeFrame: within 48 hours after surgery
measure: acute kidney injury diagnosis defined by RIFLE criteria
timeFrame: during seven days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Ho Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: