Use of a Predictive Analytics Algorithm to Optimize Weaning of Inotropes Following Pediatric Cardiac Surgery

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04600700
• Other study ID #: P00036870
• Secondary ID: R44HL117340
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: October 2021
• Source: Boston Children's Hospital
• Contact: Joshua Salvin, MD
• Phone: 6173555894
• Email: joshua.salvin[@]cardio.chboston.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 365 Days

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Device:
• Clinical Decision support system (CDSS) for inotrope weaning
A Clinical Decision Support System informed by 6-hour rolling average IDO2, will be utilized during the intervention phase of the study. The CDSS tool will be introduced in a stepped-wedge pattern. Randomization will occur by center, with time of introduction being staggered, with each center ultimately receiving the CDSS intervention. Teams in the CICU make rounds twice per day. During each of the rounds (AM and PM), the team will refer to the CDSS and the 6-hour average IDO2 (as reported on the T3 platform at the bedside computer). The clinical team will consider the CDSS in decision making around inotrope weans. If the decision is made to not utilize IDO2, the bedside clinician will complete a brief survey with rationale.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hours of inotropic support	Hours of inotropic support	12/31/21
Secondary	Hours of mechanical ventilation	Hours of mechanical ventilation	12/31/21
Secondary	Days in the Cardiac Intensive Care Unit (CICU)	Number of days in the CICU	12/31/21
Secondary	Number of central line days	Number of days with a central catheter	12/31/21
Secondary	Rate of nosocomial infection	The rate per patient day of nosocomial infection	12/31/21
Secondary	adherence to Clinical Decision Support System (CDSS)	Number of deviations from the protocol	12/31/21
Secondary	hospital cost	Hospital charges in US dollars	12/31/21