Incidence, Risk Factors, and Risk Model… | Clinical Trial

Key information

Conditions

Patients Undergoing Surgery for Congenital Heart Disease Acute Kidney Injury Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surgery for congenital heart disease

Procedure

surgery for congenital heart disease

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

Time frame: 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

Time frame: during seven days after surgery

acute kidney injury diagnosis defined by RIFLE criteria (for Risk, Injury, Failure during seven days after surgery

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Mar 7, 2014
Registry last updated: Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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