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Study About Predicting Fluid Responsiveness in Children Undergoing Neurosurgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01364103
First Posted: June 2, 2011
Last Update Posted: February 2, 2012
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.
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital
  Purpose
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 Intervention
Fluid Responsiveness Other: volume expansion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic

Further study details as provided by Jin-Tae Kim, Seoul National University Hospital:

Primary Outcome Measures:
  • 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


Enrollment: 33
Study Start Date: February 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: volume expansion
    fluid loading of 10 mL/kg colloid (voluven)
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • neurosurgery under general anesthesia
  • < 8 years old

Exclusion Criteria:

  • cardiac disease
  • pulmonary, renal and hepatic disease
  • infectious disease
  • hematologic and muscular disease
  Contacts and Locations
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): NCT01364103


Locations
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
Investigators
Study Chair: Jin-Tae Kim, MD, PhD Seoul National University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jin-Tae Kim, assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01364103     History of Changes
Other Study ID Numbers: H-1012-118-345
First Submitted: May 24, 2011
First Posted: June 2, 2011
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