Measurement of Cardiac Output and Intravascular Volume Status in Children Using COstatus (SH)

Intensive Care Clinical Trial

Official title:

Measurement of Cardiac Output and Intravascular Volume Status in Critically Ill Children Using an Ultrasound Dilution Method (COstatus)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613859
• Other study ID #: TSI-G-COstatus-12A-H
• Secondary ID: R44HL061994
• Status: Completed
• Phase: N/A
• First received: May 30, 2012
• Last updated: May 25, 2016
• Start date: January 2012
• Est. completion date: May 2014

Study information

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

Clinical Trial Summary

Assessment and monitoring of cardiac function in the pediatric intensive care unit (PICU) is an integral part of hemodynamic monitoring of critically ill patients whether it is done directly or indirectly. Measurement of cardiac output (CO) can specifically guide therapies to support the cardiovascular system in critically ill children with multi organ dysfunction. Because of the side effects involved in measuring cardiac output directly, intensive monitoring of patients is currently limited to an integrated assessment of tissue perfusion, oxygen delivery and cellular health both at regional and global levels. Currently available methods of measuring CO have their limitations and complications, and are not used routinely for bedside monitoring. Therefore, the investigators propose to use a newly developed method, termed COstatus for the monitoring of CO in patients admitted to PICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

1. Patients under 21 years

2. Presence of compensated or decompensated shock irrespective of etiology

3. Presence of an existing peripheral arterial and central venous catheters

Exclusion Criteria:

1. Patients allergic to heparin

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Intensive Care

Locations

Country	Name	City	State
United States	Shands Children's Hospital, University of Florida	Gainesville	Florida

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	Comparing CO and other clinical markers in Pediatric ICU	The objective of this study is to see if the CO measurements obtained with COstatus show a linear correlation with all other indirect and invasive methods currently used to measure CO (within acceptable range) and with the CO measured by thermodilution in the cardiac catheterization lab.	During patients stay in ICU with insitu catheter, expected average 3-4 days	No