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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Device: Clinical Decision support system (CDSS) for inotrope weaning

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Joshua Salvin, MD; Phone Number: 6173555894; Email: joshua.salvin@cardio.chboston.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Joshua W Salvin, MD; Phone Number: 617-355-7866; Email: joshua.salvin@cardio.chboston.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonates and infants with congenital heart disease following cardiac surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

CDSS weaning group; This group will be exposed to the CDSS to inform inotrope weaning

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hours of inotropic support	Hours of inotropic support	12/31/21

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Joshua W Salvin, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (ACTUAL): October 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: pediatrics; cardiac surgery; critical care; congenital heart disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: P00036870; R44HL117340 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No