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A Predictive Score System for AKI Following Pediatric Cardiac Surgery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05489263
Enrollment
2000
Registered
2022-08-05
Start date
2022-04-01
Completion date
2023-06-30
Last updated
2022-08-05

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

Conditions

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

Keywords

Pediatric Cardiac Surgery, Acute Kidney Injury, Prediction

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Prevalence of Acute Kidney InjuryUp to postoperative 7 daysAcute 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

MeasureTime frameDescription
The incidence of re-operationUp to hospital discharge, an average of 7 daysRe-exploration prescribed by surgeons due to cardiac issues or excessive chest drainage volume.
The incidence of pulmonary infectionUp to hospital discharge, an average of 7 daysAssessed by relevant guidelines of pulmonary infection
The incidence of mechanical cardiac supportUp to hospital discharge, an average of 7 daysSupported by extracorporeal membrane oxygenation from operative day to discharge or death
The incidence of dialysisUp to postoperative 7 daysThe therapeutic approach to correct renal failure
The hours of mechanical ventilationUp to postoperative 7 daysTime before first extubation
The incidence of reinbutationUp to hospital discharge, an average of 7 daysNeed for postoperative endotracheal intubation given the occurrence of respiratory or non-respiratory complication after extubation.
The incidence of tracheotomyUp to hospital discharge, an average of 7 daysThe necessary treatment for postoperative respiratory failure
The relative change of left ventricular ejection fraction (LVEF) from baseline to hospital dischargeUp 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 dischargeUp to hospital discharge, an average of 7 days(LVEDD at hospital discharge - LVEDD at baseline)/LVEDD at baseline \* 100%
The incidence of mortalityUp to hospital discharge, an average of 7 daysSpecific death reason
The cost of medical resourcesUp to hospital discharge, an average of 7 daysThe RMB patients spend during the whole hospitalization
Intensive Care Unit Discharge TimeUp to ICU discharge, an average of 5 daysTime and date when the patient is transferred to ward
Hospital Discharge TimeUp to hospital discharge, an average of 7 daysTime and date when the patient is discharged from the hospital

Other

MeasureTime frameDescription
The relative change of left ventricular ejection fraction (LVEF) from baseline to postoperative 1 yearUp to postoperative 1 year(LVEF at 1 year - LVEF at baseline)/LVEF at baseline \* 100%
The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to postoperative 1 yearUp to postoperative 1 year(LVEDD at 1 year - LVEDD at baseline)/LVEDD at baseline \* 100%

Countries

China

Contacts

Primary ContactJianhui Wang, MD
stewenwang@sina.com+86-010-88398082;

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026