Study About Predicting Fluid Responsiveness in Children Undergoing Neurosurgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01364103
First received: May 24, 2011
Last updated: January 31, 2012
Last verified: January 2012
  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 Blind (Outcomes Assessor)
Primary Purpose: Diagnostic

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • stoke volume index [ Time Frame: before and after volume loading (20 minutes) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 8 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364103

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

No publications provided by Seoul National University Hospital

Additional 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
Study First Received: May 24, 2011
Last Updated: January 31, 2012
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014