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临床试验/NCT04600700
NCT04600700Unknown不适用

Real-time Continuous Predictive Analytics Algorithm to Optimize Weaning of Inotropic Agents in Post-operative Pediatric Surgical Cardiac Patients

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
250
试验地点
1
主要终点
Hours of inotropic support

研究概览

简要总结

The objective of this study is to determine the effectiveness of a real time continuous risk analytics algorithm in the successful de-escalation of vasoactive and inotropic support in pediatric patients following cardiac surgery.

详细描述

IDO2 utilizes high fidelity continuous and intermittent patient data to feed a Bayesian model which predicts the risk of inadequate tissue oxygen delivery. This index (the IDO2) is FDA 510k cleared for pediatric patients 2 kg up to 12 years of age to continuously report the risk for inadequate tissue oxygen delivery (defined as a mixed venous oxygen saturation less than 40%). The index is continuously displayed in graphical form at the bedside. Clinical decision support systems (CDSS) such as IDO2 may inform inform the clinician when it is appropriate to de-escalate care on a critically ill. Appropriate de-escalation plays a role in the safe, efficient utilization of resources in the CICU, and may reduce duration intervals of care such as duration of support with vasoactive and inotropic drugs, mechanical ventilation and length of stay. In support of this hypothesis, the investigators for this proposed study have recently completed a retrospective, multi-center analysis of 2,556 patient encounters demonstrating that elevated IDO2 during a wean off inotropic agents is associated with weaning failure. When compared to conventional markers of cardiac output, 6-hour average IDO2 was superior to lactate elevation, fall in base deficit, and fall in urine output in discriminating inotrope weaning success from failure. Additionally, for those patients who failed inotrope wean, rescue with re-starting an inotrope was associated with a concomitant fall in IDO2. This analysis supports an underlying hypothesis that IDO2 reflects underlying patient stability, and the rescue of deteriorating physiology leads to an improved physiologic state, and hence a lower IDO2.7 Data suggest that simple CDSS which prompt discussion about management decisions, such as those made during daily ICU rounds, may improve outcomes. These CDSS are often in the form of checklists and apply to usual or standardized practices. These simplified mechanisms may not apply to the more dynamic clinical situations in which specific and intensively monitored patient populations can demonstrate variable response to drugs and recovery. In these circumstances, a CDSS utilizing a 6-hour rolling average value of IDO2, in which the physiologic response to decisions is demonstrated continuously, may inform a more rapid more efficient and safe de-escalation of vasoactive and inotropic drugs when implemented on each of the twice daily clinical work rounds in the CICU.

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
1 Day 至 365 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Neonates and infants aged 1-365 days
  • •weight greater than 3kg
  • •Gestational age greater than 36 weeks
  • •admitted to the cardiovascular intensive care uni following biventricular repairs of congenital heart disease
  • •high risk for hemodynamic instability (ie started on inotropes - milrinone, epinephrine, norepinephrine, dopamine, vasopressin) in operating room or within 6 hours cardiopulmonary bypass cessation.

排除标准

  • •Patients undergoing palliation of single ventricle heart disease
  • •surgical cases not requiring cardiopulmonary bypass
  • •cases not requiring vasoactive or inotropic support
  • •patients requiring extracorporeal membrane oxygenation (ECMO) in the perioperative period (either out of the operating room, or in the ICU prior to weaning off inotropic support)
  • •patients who died prior to weaning off inotropic support

结局指标

主要结局

Hours of inotropic support

时间窗: 12/31/21

Hours of inotropic support

次要结局

  • Number of central line days(12/31/21)
  • Hours of mechanical ventilation(12/31/21)
  • Days in the Cardiac Intensive Care Unit (CICU)(12/31/21)
  • Rate of nosocomial infection(12/31/21)
  • adherence to Clinical Decision Support System (CDSS)(12/31/21)
  • hospital cost(12/31/21)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joshua Salvin

Cardiac Intensive Care Physician

Boston Children's Hospital

研究点 (1)

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