Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability
1 other identifier
observational
52
1 country
1
Brief Summary
Hemodynamically unstable ventilated PICU \& PCICU patients, which a decision for commencement in inotropic therapy or fluid bolus has been made, will be recruited. Hemodynamic measurements will be carried out before and after therapy have been made, including customary hemodynamic parameters, echocardiography and USCOM studies. All parameters will be analyzed for fluid responsiveness or inotropic therapy prediction. Trend in USCOM parameters will be compared to echocardiography CO parameters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 25, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedMarch 16, 2021
August 1, 2020
4.1 years
October 25, 2016
March 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Raise>10% in cardiac index following therapy
20 minutes
Eligibility Criteria
Pediatric critically ill ventilated patients addmited to PICU \& PCICU
You may qualify if:
- Pediatric critically ill ventilated patients admitted to PICU \& PCICU
- Hemodynamically unstable which a decision for commencement in inotropic therapy or fluid bolus has been made
- parental concent
You may not qualify if:
- Cardiac shunt
- Aortal anomaly \\ Repair
- Tracheostomy
- Parental refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schneider's children medical center
Petah Tikva, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2016
First Posted
October 26, 2016
Study Start
July 1, 2016
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
March 16, 2021
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share