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Completed

NCT Number: NCT01613859

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

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.

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Key information

Conditions

Intensive Care

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shands Children's Hospital, University of Florida

Gainesville, Florida, 32608, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients under 21 years
  • Presence of compensated or decompensated shock irrespective of etiology
  • Presence of an existing peripheral arterial and central venous catheters

Exclusion criteria

  • Patients allergic to heparin

Treatment and study plan

Primary outcomes

  1. Comparing CO and other clinical markers in Pediatric ICU

    Time frame: During patients stay in ICU with insitu catheter, expected average 3-4 days

    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.

Sponsors and collaborators

Lead sponsor

Transonic Systems Inc.

Industry

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 7, 2012
Registry last updated
May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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