Study About Predicting Fluid Responsiveness in Children Undergoing Neurosurgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01364103
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Brief 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%.

Condition or disease Intervention/treatment Phase
Fluid Responsiveness Other: volume expansion Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Study Start Date : February 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

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

Primary Outcome Measures :
  1. stoke volume index [ Time Frame: before and after volume loading (20 minutes) ]
    Volume loading will be performed for 20 minutes. Stroke volume will be meausred before and after volume expansion

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Ages Eligible for Study:   up to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • neurosurgery under general anesthesia
  • < 8 years old

Exclusion Criteria:

  • cardiac disease
  • pulmonary, renal and hepatic disease
  • infectious disease
  • hematologic and muscular disease

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 identifier (NCT number): NCT01364103

Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of, 110-744
Seoul national university hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Study Chair: Jin-Tae Kim, MD, PhD Seoul National University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jin-Tae Kim, assistant professor, Seoul National University Hospital Identifier: NCT01364103     History of Changes
Other Study ID Numbers: H-1012-118-345
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Jin-Tae Kim, Seoul National University Hospital:
pulse pressure variation
systolic pressure variation
central venous pressure
aortic blood flow velocity variation
pleth variability index