Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02081235
Enrollment
220
Registered
2014-03-07
Start date
2014-06-30
Completion date
2016-02-29
Last updated
2016-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Surgery for Congenital Heart Disease

Keywords

congenital heart disease, acute kidney injury, risk factor, anesthesia

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.

Interventions

surgery for congenital heart disease

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global outcome) criteriaduring seven days after surgeryAcute kidney injury as defined by KDIGO criteria (Stage 1, 2, 3)

Secondary

MeasureTime frameDescription
Acute kidney injury as defined by AKIN (acute kidney injury network) criteriawithin 48 hours after surgeryAcute kidney injury as defined by AKIN (acute kidney injury network) criteria within 48 hours after surgery
acute kidney injury diagnosis defined by RIFLE criteriaduring seven days after surgeryacute kidney injury diagnosis defined by RIFLE criteria (for Risk, Injury, Failure during seven days after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026