Congenital Heart DiseaseNCT04600700
Use of a Predictive Analytics Algorithm to Optimize Weaning of Inotropes Following Pediatric Cardiac Surgery
An observational study of Congenital Heart Disease, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 day to 365 days
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Clinical Decision support system (CDSS) for inotrope weaning
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 365 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates and infants with congenital heart disease following cardiac surgery
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Joshua W Salvin, MD, 617-355-7866, joshua.salvin@cardio.chboston.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Clinical Decision support system (CDSS) for inotrope weaning
- Keywords
- cardiac surgery, congenital heart disease, critical care, pediatrics
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision support system (CDSS) for inotrope weaningDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CDSS weaning group | This group will be exposed to the CDSS to inform inotrope weaning Receives: Device: Clinical Decision support system (CDSS) for inotrope weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours of inotropic support
Hours of inotropic support
Measured: 12/31/21
Secondary outcomes (6)
Hours of mechanical ventilation
Hours of mechanical ventilation
Measured: 12/31/21
Days in the Cardiac Intensive Care Unit (CICU)
Number of days in the CICU
Measured: 12/31/21
Number of central line days
Number of days with a central catheter
Measured: 12/31/21
Rate of nosocomial infection
The rate per patient day of nosocomial infection
Measured: 12/31/21
adherence to Clinical Decision Support System (CDSS)
Number of deviations from the protocol
Measured: 12/31/21
hospital cost
Hospital charges in US dollars
Measured: 12/31/21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Jul 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Joshua Salvin, Boston Children's Hospital
- Investigators
- Joshua W Salvin, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600700
- Sponsor's protocol ID
- P00036870
- Other IDs
- R44HL117340
- Status last verified
- Oct 2021
- First submitted
- 19 Oct 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40298483
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Continuous Predictive Analytics Algorithm to Optimize Weaning of Inotropic Agents in Post-operative Pediatric Surgical Cardiac Patients
- ClinicalTrials.gov ID
- NCT04600700
- Acronym / sponsor ID
- P00036870
- Conditions
- Congenital Heart Disease
- Keywords
- cardiac surgery, congenital heart disease, critical care, pediatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDSS weaning group | – | Device: Clinical Decision support system (CDSS) for inotrope weaningThis group will be exposed to the CDSS to inform inotrope weaning |
Who may qualify
- Ages
- 1 day to 365 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates and infants with congenital heart disease following cardiac surgery
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision support system (CDSS) for inotrope weaningA 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. | Device | CDSS weaning group |
Primary outcome
Hours of inotropic support
Time frame: 12/31/21
Hours of inotropic support
6 secondary outcomes
Hours of mechanical ventilation
Time frame: 12/31/21
Days in the Cardiac Intensive Care Unit (CICU)
Time frame: 12/31/21
Number of central line days
Time frame: 12/31/21
Rate of nosocomial infection
Time frame: 12/31/21
adherence to Clinical Decision Support System (CDSS)
Time frame: 12/31/21
hospital cost
Time frame: 12/31/21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Derived from this study: PubMed 40298483Gazit 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua W Salvin, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua Salvin, MD (6173555894, joshua.salvin@cardio.chboston.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hours of inotropic support (time frame: 12/31/21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.