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NCT01364103 Clinical Trial

Study About Predicting Fluid Responsiveness in Children Undergoing Neurosurgery

Fluid Responsiveness Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01364103
Other study ID # H-1012-118-345
Secondary ID
Status Completed
Phase N/A
First received May 24, 2011
Last updated January 31, 2012
Start date February 2011
Est. completion date May 2011

Study information
Verified date January 2012
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate static and dynamic parameters, echocardiographic parameters, and pleth variability index for predicting fluid responsiveness in children. Children who need volume expansion will receive colloid 10 mL/kg. Blood pressure, heart rate, central venous pressure, systolic pressure variation, pulse pressure variation, delta down, aortic blood flow velocity variation, inferior vena cava diameter variation, and pleth variability index will be measure before and after volume expansion. Patients will be classified as responders to volume loading if stoke volume index increase by at least 15%.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 8 Years
Eligibility Inclusion Criteria:

- neurosurgery under general anesthesia

- < 8 years old

Exclusion Criteria:

- cardiac disease

- pulmonary, renal and hepatic disease

- infectious disease

- hematologic and muscular disease

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• volume expansion
fluid loading of 10 mL/kg colloid (voluven)

Locations
Country Name City State
Korea, Republic of Seoul national university hospital Seoul
Korea, Republic of Seoul national university hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary stoke volume index Volume loading will be performed for 20 minutes. Stroke volume will be meausred before and after volume expansion before and after volume loading (20 minutes) No
See also
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Completed NCT03713008 - Assessment Of Carotid Flow During General Anesthesia N/A
Completed NCT02277353 - Evaluation of SVV From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery N/A
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Recruiting NCT04186416 - Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients
Completed NCT01996956 - Prediction of Fluid Responsiveness by NICOM (Non-invasive Cardiac Output Monitoring) in Children With Congenital Heart Disease After Cardiac Surgery N/A
Enrolling by invitation NCT04388995 - SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia N/A
Not yet recruiting NCT04574011 - Fluid Responsiveness in Spontaneously Ventilating Patient N/A
Completed NCT01821742 - Echocardiography in Kids Intensive Care Decision Support
Completed NCT04802668 - Factors Influencing of Pulse Pressure Variation (PPV)
Not yet recruiting NCT06254456 - Fluid Responsiveness in Prone Patients N/A
Completed NCT02789124 - Diagnostic Value of Passive Leg Raise Induced Changes in Carotid Artery Flow Time to Predict Fluid Responsiveness in Critically Ill Patients N/A
Withdrawn NCT01898975 - A Gray Zone Approach to Stroke Volume Variation Derived From NICOM N/A
Completed NCT02040948 - Accuracy of Pulse Pressure Variation and of Pleth Variability Index to Predict the Response to a Fluid Challenge N/A