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Clinical Trials/NCT05489263
NCT05489263
Unknown
Not Applicable

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

China National Center for Cardiovascular Diseases1 site in 1 country2,000 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
China National Center for Cardiovascular Diseases
Enrollment
2000
Locations
1
Primary Endpoint
The Prevalence of Acute Kidney Injury
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
June 30, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
China National Center for Cardiovascular Diseases
Responsible Party
Principal Investigator
Principal Investigator

Jianhui Wang

Department of Anesthesiology

China National Center for Cardiovascular Diseases

Eligibility Criteria

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

Outcomes

Primary Outcomes

The Prevalence of Acute Kidney Injury

Time Frame: 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 Outcomes

  • The incidence of tracheotomy(Up to hospital discharge, an average of 7 days)
  • The incidence of pulmonary infection(Up to hospital discharge, an average of 7 days)
  • The hours of mechanical ventilation(Up to postoperative 7 days)
  • The cost of medical resources(Up to hospital discharge, an average of 7 days)
  • Intensive Care Unit Discharge Time(Up to ICU discharge, an average of 5 days)
  • The relative change of left ventricular ejection fraction (LVEF) from baseline to hospital discharge(Up to hospital discharge, an average of 7 days)
  • The incidence of reinbutation(Up to hospital discharge, an average of 7 days)
  • The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to hospital discharge(Up to hospital discharge, an average of 7 days)
  • The incidence of mortality(Up to hospital discharge, an average of 7 days)
  • The incidence of dialysis(Up to postoperative 7 days)
  • The incidence of re-operation(Up to hospital discharge, an average of 7 days)
  • The incidence of mechanical cardiac support(Up to hospital discharge, an average of 7 days)
  • Hospital Discharge Time(Up to hospital discharge, an average of 7 days)

Study Sites (1)

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