A Predictive Score System for AKI Following Pediatric Cardiac Surgery
- Conditions
- Surgery--ComplicationsAcute Kidney InjuryCongenital Heart Disease
- Interventions
- Other: No intervention
- Registration Number
- NCT05489263
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
- < 18 years old
- Pediatric patients undergoing cardiac surgery in Fuwai Hospital
- Supported by dialysis for renal failure prior to cardiac procedure
- Previously received a renal transplant
- Lack of preoperative or postoperative serum creatinine measurements
- Guardians' refusal on informed consent sign
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AKI No intervention AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation. No-AKI No intervention No-AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation.
- Primary Outcome Measures
Name Time Method The Prevalence of Acute Kidney Injury Up to postoperative 7 days Acute Kidney Injury was defined by Kidney Disease Improving Global Outcomes (KDIGO) Criteria. Accordingly, AKI was classified as stage 1, stage 2 and stage 3.
- Secondary Outcome Measures
Name Time Method The incidence of tracheotomy Up to hospital discharge, an average of 7 days The necessary treatment for postoperative respiratory failure
The incidence of pulmonary infection Up to hospital discharge, an average of 7 days Assessed by relevant guidelines of pulmonary infection
The hours of mechanical ventilation Up to postoperative 7 days Time before first extubation
The cost of medical resources Up to hospital discharge, an average of 7 days The RMB patients spend during the whole hospitalization
Intensive Care Unit Discharge Time Up to ICU discharge, an average of 5 days Time and date when the patient is transferred to ward
The relative change of left ventricular ejection fraction (LVEF) from baseline to hospital discharge Up to hospital discharge, an average of 7 days (LVEF at hospital discharge - LVEF at baseline)/LVEF at baseline \* 100%
The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to hospital discharge Up to hospital discharge, an average of 7 days (LVEDD at hospital discharge - LVEDD at baseline)/LVEDD at baseline \* 100%
The incidence of reinbutation Up to hospital discharge, an average of 7 days Need for postoperative endotracheal intubation given the occurrence of respiratory or non-respiratory complication after extubation.
The incidence of mortality Up to hospital discharge, an average of 7 days Specific death reason
The incidence of dialysis Up to postoperative 7 days The therapeutic approach to correct renal failure
The incidence of re-operation Up to hospital discharge, an average of 7 days Re-exploration prescribed by surgeons due to cardiac issues or excessive chest drainage volume.
The incidence of mechanical cardiac support Up to hospital discharge, an average of 7 days Supported by extracorporeal membrane oxygenation from operative day to discharge or death
Hospital Discharge Time Up to hospital discharge, an average of 7 days Time and date when the patient is discharged from the hospital
Trial Locations
- Locations (1)
Fuwai Hospital
🇨🇳Beijing, Beijing, China