Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients

Cardiac Output Clinical Trial

— GCH  

Official title:

Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853437
• Other study ID #: TSI-G-COSTATUS-2A-H
• Secondary ID: 2R44HL061994-04A
• Status: Completed
• Phase: N/A
• First received: February 27, 2009
• Last updated: May 25, 2016
• Start date: January 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2016
• Source: Transonic Systems Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The ability to measure cardiac output (CO) accurately and reproducibly at frequent intervals remains elusive to the clinician caring for critically ill pediatric patients even though a large proportion of these children are known to have hemodynamic compromise as a result of their illness. Current techniques used in adults to measure CO are not suitable for routine use with pediatric patients. A new ultrasound dilution approach provides an opportunity to measure cardiac output and blood volumes in pediatric patients. The main aim of this study is to compare CO measured by the new method with the clinician's estimate and implied CO from the measurement of the arteriovenous oxygen content difference.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• Patients with in situ central venous and arterial catheters

• Ability to draw blood from arterial and central venous catheters

• Presence of parent or guardian to provide consent

Exclusion Criteria:

• Patients over 16 years of age.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Output
• Critical Illness

Locations

Country	Name	City	State
United States	Golisano Children's Hospital	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Transonic Systems Inc.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare CO measured by the new method with clinician's estimate and implied CO from measurement of arteriovenous oxygen content difference.		5-8 minutes minimum	No
Secondary	Measure blood volumes to compare effects of volume infusion and furosemide.		5-8 minutes minimum	No