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NCT02945748 Clinical Trial

Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability

Hemodynamic Instability Clinical Trial

Official title:
Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02945748
Other study ID # 0693-14-RMC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2016
Est. completion date August 2020

Study information
Verified date August 2020
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Cardiac shunt - Aortal anomaly \ Repair - Tracheostomy - Parental refusal to participate

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Schneider's children medical center Petach tikva

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Raise>10% in cardiac index following therapy 20 minutes
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