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

October 1, 2021 updated by: Joshua Salvin, Boston Children's Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hours of inotropic support
Time Frame: 12/31/21
Hours of inotropic support
12/31/21

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hours of mechanical ventilation
Time Frame: 12/31/21
Hours of mechanical ventilation
12/31/21
Days in the Cardiac Intensive Care Unit (CICU)
Time Frame: 12/31/21
Number of days in the CICU
12/31/21
Number of central line days
Time Frame: 12/31/21
Number of days with a central catheter
12/31/21
Rate of nosocomial infection
Time Frame: 12/31/21
The rate per patient day of nosocomial infection
12/31/21
adherence to Clinical Decision Support System (CDSS)
Time Frame: 12/31/21
Number of deviations from the protocol
12/31/21
hospital cost
Time Frame: 12/31/21
Hospital charges in US dollars
12/31/21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joshua W Salvin, MD, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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