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

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ClinicalTrials.gov Identifier: NCT02945748
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

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.


Condition or disease
Hemodynamic Instability

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability
Study Start Date : July 2016
Estimated Primary Completion Date : January 2018



Primary Outcome Measures :
  1. Raise>10% in cardiac index following therapy [ Time Frame: 20 minutes ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric critically ill ventilated patients addmited to PICU & PCICU
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945748


Contacts
Contact: Eran Shostak, MD eransho@clalit.org.il

Locations
Israel
Schneider's children medical center Recruiting
Petach tikva, Israel
Contact: Ofer Schiller, MD    972-3-9253114      
Sponsors and Collaborators
Rabin Medical Center

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02945748     History of Changes
Other Study ID Numbers: 0693-14-RMC
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rabin Medical Center:
pediatric
cardiac output
fluid responsiveness
critically ill
hemodynamic monitoring

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes