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临床试验/NCT05489263
NCT05489263Unknown不适用

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

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
The Prevalence of Acute Kidney Injury

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
0 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • < 18 years old
  • Pediatric patients undergoing cardiac surgery in Fuwai Hospital

排除标准

  • 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

结局指标

主要结局

The Prevalence of Acute Kidney Injury

时间窗: 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.

次要结局

  • 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)

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Jianhui Wang

Department of Anesthesiology

China National Center for Cardiovascular Diseases

研究点 (1)

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