Recruiting

Predictive Analytics

Sponsor:

Boston Children's Hospital

Code:

NCT04600700

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Clinical Decision support system (CDSS) for inotrope weaning

Study Details

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

Study ID

NCT04600700

Start date

Jul 1, 2021

Status verified date

Oct, 2021

Completion date

Mar 1, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

CDSS weaning group

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

Interventions

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.

Primary outcome measure

  • Hours of inotropic support [ Time Frame: 12/31/21 ]

Central Contacts and Locations

Central contacts

Joshua Salvin, MD

6173555894joshua.salvin@cardio.chboston.org

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Joshua W Salvin, MD

617-355-7866joshua.salvin@cardio.chboston.org

More Information

Sponsor

Boston Children's Hospital

Last update posted

Oct 8, 2021

Last verified

Oct, 2021

Keywords

  • cardiac surgery
  • congenital heart disease
  • critical care
  • pediatrics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2021-10-08.