Prediction of Fluid Responsiveness by NICOM (Non-invasive Cardiac Output Monitoring) in Children With Congenital Heart Disease After Cardiac Surgery

NCT ID: NCT01996956

Last Updated: 2013-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fluid Responsiveness

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Volume loading

Group Type OTHER

volume expansion

Intervention Type OTHER

fluid loading of 10 ml/kg colloid or blood product

Interventions

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volume expansion

fluid loading of 10 ml/kg colloid or blood product

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

1 Day

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Seoul national university hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 25926311 (View on PubMed)

Other Identifiers

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H-1303-114-478

Identifier Type: -

Identifier Source: org_study_id