Status:

COMPLETED

NIRS Predict Low Cardiac Output State in Neonates and Infants in Cardiac Surgery

Lead Sponsor:

Mayo Clinic

Collaborating Sponsors:

Nonin Medical, Inc

Conditions:

Congenital Heart Disease

Eligibility:

All Genders

Up to 3 years

Brief Summary

Neonates and infants that have cardiac surgery with cardiopulmonary bypass (CPB) for congenital heart disease are at great risk for experiencing life-threatening low cardiac output syndrome (LCOS) in ...

Eligibility Criteria

Inclusion

  • Inclusion:
  • pediatric patients 0-3 years of age
  • scheduled to undergo cardiopulmonary bypass surgery (CPB) for repair of congenital heart defects
  • Exclusion:
  • weight \< 2 kg or \> 20 kg
  • greater than 3 years of age
  • thrombosed femoral arteries
  • prior fasciotomies
  • currently on extracorporeal membrane oxygenation (ECMO)

Exclusion

    Key Trial Info

    Start Date :

    May 1 2013

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2015

    Estimated Enrollment :

    35 Patients enrolled

    Trial Details

    Trial ID

    NCT01849120

    Start Date

    May 1 2013

    End Date

    September 1 2015

    Last Update

    April 14 2017

    Active Locations (1)

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    Mayo Clinic in Rochester

    Rochester, Minnesota, United States, 55905