Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique

NCT00851422 | Completed

• 2 other identifiers: TSI-C-COSTATUS-5A-H2R44HL061994-04A2
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Output

Keywords

Ultrasound Dilution; Cardiac Output; Validation of measured ultrasound dilution cardiac output

Outcome Measures

Primary Outcomes (1)

• Validation of cardiac output measured by ultrasound dilution with cardiac output measured by thermodilution.

  5-8 minutes minimum

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Transonic Systems Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 18496416 BACKGROUND

• 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.

  PMID: 21499176 RESULT

Study Officials

• Jeffery J Kim, MD

  Texas Children's Hospital, Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: February 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 31, 2012

Record last verified: 2012-05

Locations

US (1)