Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique

NCT ID: NCT00851422

Last Updated: 2012-05-31

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

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Output

Keywords

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Ultrasound Dilution Cardiac Output Validation of measured ultrasound dilution cardiac output

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Transonic Systems Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffery J Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Children's Hospital, Baylor College of Medicine

Locations

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Texas Children's Hospital

Houston, Texas, United States

Site Status

Countries

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United States

References

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Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.

Reference Type BACKGROUND
PMID: 18496416 (View on PubMed)

Crittendon I 3rd, Dreyer WJ, Decker JA, Kim JJ. Ultrasound dilution: an accurate means of determining cardiac output in children. Pediatr Crit Care Med. 2012 Jan;13(1):42-6. doi: 10.1097/PCC.0b013e3182196804.

Reference Type RESULT
PMID: 21499176 (View on PubMed)

Other Identifiers

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2R44HL061994-04A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TSI-C-COSTATUS-5A-H

Identifier Type: -

Identifier Source: org_study_id