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OpenTrials
Completed

NCT Number: NCT01996956

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

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.

Completed

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Key information

Age range

1 day–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul national university hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

volume expansion

Other

fluid loading of 10 ml/kg colloid or blood product

Primary outcomes

  1. stroke volume index

    Time frame: before and after volume loading (20 min)

    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.

Secondary outcomes

  1. Cardiac index

    Time frame: before and after fluid loading (20 min)

    Cardiac index measured by transesophageal echocardiography and NICOM monitor were compared before and after fluid loading for 20 min.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 27, 2013
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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