NCT01364103

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

May 24, 2011

Last Update Submit

January 31, 2012

Conditions

Fluid Responsiveness

Keywords

pulse pressure variationsystolic pressure variationcentral venous pressureaortic blood flow velocity variationpleth variability index

Outcome Measures

Primary Outcomes (1)

  • 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)

Interventions

volume expansionOTHER

fluid loading of 10 mL/kg colloid (voluven)

Eligibility Criteria

AgeUp to 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • neurosurgery under general anesthesia
  • \< 8 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul national university hospital

Seoul, 110-744, South Korea

Location

Seoul national university hospital

Seoul, South Korea

Location

Related Publications (1)

  • Byon HJ, Lim CW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness in mechanically ventilated children undergoing neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91. doi: 10.1093/bja/aes467. Epub 2012 Dec 18.

    PMID: 23250892DERIVED

Study Officials

  • Jin-Tae Kim, MD, PhD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 24, 2011

First Posted

June 2, 2011

Study Start

February 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations

KR(2)