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

NCT ID: NCT00853437

Last Updated: 2016-05-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-05-31

Brief 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.

Conditions

Cardiac Output

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Transonic Systems Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Powers, MD

Role: PRINCIPAL_INVESTIGATOR

Golisano Children's Hospital

Locations

Golisano Children's Hospital

Rochester, New York, United States

Countries

United States

References

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)

Other Identifiers

2R44HL061994-04A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TSI-G-COSTATUS-2A-H

Identifier Type: -

Identifier Source: org_study_id