A Predictive Score System for AKI Following Pediatric Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Derivation and Validation of A Predictive Score System for Acute Kidney Injury Following Pediatric Cardiac Surgery

Conditions
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Congenital Heart Disease, Surgery--Complications, Acute Kidney Injury

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: < 18 years old Pediatric patients undergoing cardiac surgery in Fuwai Hospital Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AKI<br>AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation. | Other: No intervention<br>* No intervention<br>|
| No-AKI<br>No-AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation. | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Prevalence of Acute Kidney Injury | 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. | Up to postoperative 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of dialysis | The therapeutic approach to correct renal failure | Up to postoperative 7 days | 
| The hours of mechanical ventilation | Time before first extubation | Up to postoperative 7 days | 
| The incidence of reinbutation | Need for postoperative endotracheal intubation given the occurrence of respiratory or non-respiratory complication after extubation. | Up to hospital discharge, an average of 7 days | 
| The incidence of tracheotomy | The necessary treatment for postoperative respiratory failure | Up to hospital discharge, an average of 7 days | 
| The incidence of re-operation | Re-exploration prescribed by surgeons due to cardiac issues or excessive chest drainage volume. | Up to hospital discharge, an average of 7 days | 
| The incidence of mechanical cardiac support | Supported by extracorporeal membrane oxygenation from operative day to discharge or death | Up to hospital discharge, an average of 7 days | 
| The incidence of mortality | Specific death reason | Up to hospital discharge, an average of 7 days | 
| The incidence of pulmonary infection | Assessed by relevant guidelines of pulmonary infection | Up to hospital discharge, an average of 7 days | 
| The cost of medical resources | The RMB patients spend during the whole hospitalization | Up to hospital discharge, an average of 7 days | 
| Intensive Care Unit Discharge Time | Time and date when the patient is transferred to ward | Up to ICU discharge, an average of 5 days | 
| Hospital Discharge Time | Time and date when the patient is discharged from the hospital | Up to hospital discharge, an average of 7 days | 
| The relative change of left ventricular ejection fraction (LVEF) from baseline to hospital discharge | (LVEF at hospital discharge - LVEF at baseline)/LVEF at baseline * 100% | Up to hospital discharge, an average of 7 days | 
| The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to hospital discharge | (LVEDD at hospital discharge - LVEDD at baseline)/LVEDD at baseline * 100% | Up to hospital discharge, an average of 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediction, Pediatric Cardiac Surgery, Acute Kidney Injury