NCT01996956

Brief Summary

The purpose of this study is to evaluate the ability of fluid responsiveness by stroke volume variation value of NICOM(Noninvasive cardiac output monitor)system during congenital cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

May 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

5 months

First QC Date

November 17, 2013

Last Update Submit

November 21, 2013

Conditions

Fluid Responsiveness

Keywords

stroke volume variation,cardiac output,fluid responsiveness,noninvasive cardiac output monitor

Outcome Measures

Primary Outcomes (1)

  • stroke volume index

    Volume loading was performed for 20 minutes. Stroke volume measured before and after volume expansion using transesophageal echocardiography. And, stroke volume variation of NICOM monitor was recorded before fluid loading.

    before and after volume loading (20 min)

Secondary Outcomes (1)

  • Cardiac index

    before and after fluid loading (20 min)

Study Arms (1)

Volume loading

OTHER
Other: volume expansion

Interventions

volume expansionOTHER

fluid loading of 10 ml/kg colloid or blood product

Volume loading

Eligibility Criteria

Age1 Day - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • congenital cardiac surgery
  • \< 6 years old
  • who were required the evaluation by transesophageal echocardiography

You may not qualify if:

  • right heart failure
  • supported by more than 2 inotropic agents
  • reduced kidney function
  • any valvar stenosis
  • moderate or severe tricuspid regurgitation
  • single ventricle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Lee JH, No HJ, Song IK, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness using a non-invasive cardiac output monitor in children undergoing cardiac surgery. Br J Anaesth. 2015 Jul;115(1):38-44. doi: 10.1093/bja/aev109. Epub 2015 Apr 29.

    PMID: 25926311DERIVED

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
Ph.D

Study Record Dates

First Submitted

November 17, 2013

First Posted

November 27, 2013

Study Start

May 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

KR(1)