Overview

This trial is active, not recruiting.

Conditions cardiac output, blood pressure
Sponsor Children's Hospital Boston
Start date December 2009
End date June 2011
Trial size 186 participants
Trial identifier NCT01030445, 09-11-0597

Summary

To assess whether a non-invasive cardiac output monitor can follow heart function in children during treatments in the hospital. To establish a normal reference for children who are well and awake.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Mean arterial pressure greater than 1 standard deviation above the mean based on age
Mean arterial pressure greater than 1 standard deviation below the mean based on age
Mean arterial pressure within the standard deviation of the mean based on age

Primary Outcomes

Measure
To document trends in cardiac output (CO) and systemic vascular resistance (SVR) in subjects undergoing systematic changes in mean arterial pressure (MAP) and to assess intra-individual variability for those with normal blood pressure
time frame: During hospitalization until discharge

Secondary Outcomes

Measure
To establish age relevant hemodynamic norms as measured by the electrical velocimetry (EV) cardiac monitor for trend parameters
time frame: Measurements obtain on day of discharge

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Medical patients without complex medical history with expected hospital stay for less than 10 days - Uncomplicated Medical Patients as define as (1) Previously healthy children or (2) Children with diagnosis of a single chronic medical disorder that is not associated with cardiac dysfunction Exclusion Criteria: - Congenital heart disease with and without repair (includes PFO, ASD and PDA, cardiac valve disease or pulmonary hypertension - Chronic lung disease (except asthma) - Abnormal Hemoglobin (SSD)

Additional Information

Official title A Pilot Study: Cardiac Function as Measured by Non-invasive Electrical Velocimetry Cardiac Monitor in Hospitalized Children From Acute Illness (Disease) to Recovery (Health).
Description The aim of the study is to evaluate the ability of a new FDA-approved non-invasive Electrical Velocimetry (EV) cardiac monitor called AESCULON (Cardiotronic Inc, La Jolla CA) to detect and trend hemodynamic changes in hospitalized ambulatory pediatric patients during recovery from acute illness. We postulate that if the cardiac monitor can trend hemodynamic changes in hypertensive patients whose mean arterial pressure (MAP) decreases to normal levels, or hypotensive patients whose MAP increases to normal levels over several days, it may improve our understanding of different disease processes and allow us to improve care. We also seek to establish normative data for different measures provided by the AESCULON monitor - specifically cardiac output (CO) and systemic vascular resistance (SVR), which are the prime determinants of MAP.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Children's Hospital Boston.