Clinical trial NCT05489263: A Predictive Score System for AKI Following Pediatric Cardiac Surgery
Official title: Derivation and Validation of A Predictive Score System for Acute Kidney Injury Following Pediatric Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Surgery--Complications
Acute Kidney Injury
Keywords: Pediatric Cardiac Surgery
Acute Kidney Injury
Prediction
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-08-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort of pediatric patients of 18 years old and younger who have cardiac procedures in Fuwai Hospital, Beijing, China will be consecutively enrolled.

Brief summary: Acute kidney injury (AKI) has been recognized as a typical post- operative complication among the children undergoing surgical repair of a congenital cardiac defect. It is associated with increased morbidity and mortality in the intensive care unit and a higher utilization of hospital resources. However, how to precisely identify those who have greater hazard to encounter postoperative AKI seems ambiguous.

Detailed description: The development of AKI is common following cardiac surgery whether in adult or pediatric population. Not only severe AKI like dialysis support, but also mild kidney injury has profound influence on increased subsequent morbidities and mortality.

Pediatric patients who undergo cardiac procedures are characterized by lower weight, younger age, complicated cardiac anomaly and poor resistance to surgical insults. Thus, in comparison with adults, their AKI risk is relatively higher.

At present there has been no specific intervention regarding AKI prevention and therapy. Establishing a risk score based on patient characteristics and surgical information to effectively predict postoperative AKI risk is therefore imperative. It can serve as a decision-making tool to facilitate patient management with regard to kidney prognosis.

This program is aimed at developing and internally validating a AKI risk score post cardiac surgery in a Chinese pediatric population.

Eligibility criteria: Inclusion Criteria:

1. \< 18 years old
2. Pediatric patients undergoing cardiac surgery in Fuwai Hospital

Exclusion Criteria:

1. Supported by dialysis for renal failure prior to cardiac procedure
2. Previously received a renal transplant
3. Lack of preoperative or postoperative serum creatinine measurements
4. Guardians' refusal on informed consent sign

Primary outcomes:
measure: The Prevalence of Acute Kidney Injury
timeFrame: Up to postoperative 7 days
Secondary outcomes:
measure: The incidence of dialysis
timeFrame: Up to postoperative 7 days
measure: The hours of mechanical ventilation
timeFrame: Up to postoperative 7 days
measure: The incidence of reinbutation
timeFrame: Up to hospital discharge, an average of 7 days
measure: The incidence of tracheotomy
timeFrame: Up to hospital discharge, an average of 7 days
measure: The incidence of re-operation
timeFrame: Up to hospital discharge, an average of 7 days
measure: The incidence of mechanical cardiac support
timeFrame: Up to hospital discharge, an average of 7 days
measure: The incidence of mortality
timeFrame: Up to hospital discharge, an average of 7 days
measure: The incidence of pulmonary infection
timeFrame: Up to hospital discharge, an average of 7 days
measure: The cost of medical resources
timeFrame: Up to hospital discharge, an average of 7 days
measure: Intensive Care Unit Discharge Time
timeFrame: Up to ICU discharge, an average of 5 days
measure: Hospital Discharge Time
timeFrame: Up to hospital discharge, an average of 7 days
measure: The relative change of left ventricular ejection fraction (LVEF) from baseline to hospital discharge
timeFrame: Up to hospital discharge, an average of 7 days
measure: The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to hospital discharge
timeFrame: Up to hospital discharge, an average of 7 days
Other outcomes:
measure: The relative change of left ventricular ejection fraction (LVEF) from baseline to postoperative 1 year
timeFrame: Up to postoperative 1 year
measure: The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to postoperative 1 year
timeFrame: Up to postoperative 1 year
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medial Sciences
name: Jianhui Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: