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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01821742
Other study ID # IRAS ID 121440
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2013
Est. completion date July 2013

Study information

Verified date July 2019
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender All
Age group N/A to 16 Years
Eligibility Inclusion Criteria:

- Any ventilated child requiring fluid bolus therapy on the PICU for clinical indications

Exclusion Criteria:

- Arrythmia

- Intracardiac shunt

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ultrasound cardiac output measurement


Locations

Country Name City State
United Kingdom Imperial College Healthcare NHS Trust London

Sponsors (1)

Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

McLean JR, Inwald DP. The utility of stroke volume variability as a predictor of fluid responsiveness in critically ill children: a pilot study. Intensive Care Med. 2014 Feb;40(2):288-9. doi: 10.1007/s00134-013-3171-x. Epub 2013 Dec 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fluid responsiveness 10% increase in cardiac output following fluid bolus Immediate
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