NCT00853437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

February 27, 2009

Last Update Submit

May 25, 2016

Conditions

Cardiac Output

Keywords

Comparison of CO by new method to clinician's estimate and implied CO from the measurement of arteriovenous oxygen content difference.

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Measure blood volumes to compare effects of volume infusion and furosemide.

    5-8 minutes minimum

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients (up to 16 years of age ) in the ICU with in situ central venous and arterial catheters.

You may qualify if:

  • 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

You may not qualify if:

  • Patients over 16 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golisano Children's Hospital

Rochester, New York, 14642, United States

Location

Related 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.

    PMID: 18496416BACKGROUND

Study Officials

  • Karen Powers, MD

    Golisano Children's Hospital

    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 27, 2009

First Posted

March 2, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 27, 2016

Record last verified: 2016-05

Locations

US(1)