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

NCT04600700 | Unknown FDA Device

• 2 other identifiers: P00036870R44HL117340
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Heart Disease

Keywords

cardiac surgery; congenital heart disease; critical care; pediatrics

Outcome Measures

Primary Outcomes (1)

• Hours of inotropic support

  Hours of inotropic support

  12/31/21

Secondary Outcomes (6)

• Hours of mechanical ventilation

  12/31/21

• Days in the Cardiac Intensive Care Unit (CICU)

  12/31/21

• Number of central line days

  12/31/21

• Rate of nosocomial infection

  12/31/21

• adherence to Clinical Decision Support System (CDSS)

  12/31/21

Study Arms (1)

CDSS weaning group

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

Device: Clinical Decision support system (CDSS) for inotrope weaning

Interventions

Clinical Decision support system (CDSS) for inotrope weaning DEVICE

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.

CDSS weaning group

Eligibility Criteria

• Age: 1 Day - 365 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates and infants with congenital heart disease following cardiac surgery

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

• Gazit AZ, Futterman C, Baronov D, Tomczak A, Goldsmith MP, Talisa VB, Nadkarni VM, Laussen PC, Salvin JW. Risk Analytics Clinical Decision Support Decreases Duration of Vasoactive Infusions Following Pediatric Cardiac Surgery: A Multicenter Before and After Clinical Trial. Crit Care Med. 2025 Jul 1;53(7):e1355-e1364. doi: 10.1097/CCM.0000000000006682. Epub 2025 Apr 29.

  PMID: 40298483 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Joshua W Salvin, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Salvin, MD

CONTACT

6173555894; joshua.salvin@cardio.chboston.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Intensive Care Physician

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: July 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 1, 2023
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)