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Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique (BCM)

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ClinicalTrials.gov Identifier: NCT00851422
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : May 31, 2012
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Transonic Systems Inc.

Brief Summary:
Accurate cardiac output determination is a commonly used and important index of myocardial performance. The thermodilution method using a pulmonary artery catheter is the most common approach to cardiac output determination; however, placement of the pulmonary artery catheter is not without risk and at times can be problematic. Ultrasound dilution measurement has been shown to correlate with measured cardiac output in animal models and adults, but it has not been validated in pediatric patients. This study will validate the accuracy of ultrasound dilution measurements of cardiac output to thermodilution measurements of cardiac output in pediatric patients.

Condition or disease
Cardiac Output

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique
Study Start Date : February 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound




Primary Outcome Measures :
  1. Validation of cardiac output measured by ultrasound dilution with cardiac output measured by thermodilution. [ Time Frame: 5-8 minutes minimum ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any pediatric patient (aged < 18 years) who has undergone cardiac transplantation and is already scheduled for a biopsy will be offered the opportunity to participate.
Criteria

Inclusion Criteria:

  • Transplant patients undergoing hemodynamic evaluation in the catheterization laboratory that are less than 18 years of age and have structurally normal hearts.

Exclusion Criteria:

  • Patient's age greater than 18 years, and any structural abnormality of the heart.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851422


Locations
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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Transonic Systems Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jeffery J Kim, MD Texas Children's Hospital, Baylor College of Medicine