- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01821742
Echocardiography in Kids Intensive Care Decision Support (ECHOKIDS)
July 3, 2019 updated by: Imperial College London
Echocardiography in Kids Intensive Care Decision Support - is Focused Echocardiography Superior to Pressure Derived Measurements at Predicting Fluid Responsiveness in Critically Ill Children?
A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU.
These parameters will be measured pre and post fluid bolus in children prescribed fluid bolus therapy for clinical indications on the PICU.
Children will be classified as responders (>10% increase in cardiac output) and non responders (<10% increase).
Appropriate statistical tests will be performed to determine the most useful predictor of an increase in cardiac output following a fluid bolus.
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, W2 1NY
- Imperial College Healthcare NHS Trust
-
-
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
Ages Eligible for Study
No older than 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Shocked children on PICU
Description
Inclusion Criteria:
- Any ventilated child requiring fluid bolus therapy on the PICU for clinical indications
Exclusion Criteria:
- Arrythmia
- Intracardiac shunt
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 |
Intervention / Treatment |
|---|---|
|
Children requiring fluid bolus on PICU
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fluid responsiveness
Time Frame: Immediate
|
10% increase in cardiac output following fluid bolus
|
Immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Inwald, MB BChir, Imperial College London
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
March 1, 2013
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
March 22, 2013
First Submitted That Met QC Criteria
March 29, 2013
First Posted (Estimate)
April 1, 2013
Study Record Updates
Last Update Posted (Actual)
July 8, 2019
Last Update Submitted That Met QC Criteria
July 3, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- IRAS ID 121440
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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