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



Status:Withdrawn
Conditions:Cardiology, Hospital
Therapuetic Areas:Cardiology / Vascular Diseases, Other
Healthy:No
Age Range:Any - 16
Updated:4/21/2016
Start Date:August 2004
End Date:July 2008

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

Each year in the United States more than 30,000 children are admitted to intensive care
units. The majority of these children have some degree of heart instability during their
stay, yet there is currently no routine way to measure the actual amount of blood that the
heart pumps. The ability to measure the amount of blood that the heart pumps accurately and
easily at frequent intervals would be very helpful to the doctor caring for these children
because many of them have poor heart function as a result of their illnesses. Current
techniques used in adults to measure output of the heart are either not readily transferred
to children or demand difficult invasive procedures. Because of this, the amount of blood
that the heart pumps cannot be measured with enough frequency to help guide care. Despite
this reality, accurate measurements of the amount of blood that the heart pumps in these
patients at crucial points in their illnesses would allow for more accurate use of
potentially harmful procedures and could possibly improve the outlook for these children.
Likewise, being able to correctly measure blood volume could provide a better way to
estimate the pressure on the heart and improve treatment.

The purpose of this research study is to compare the accuracy of doctor estimates of heart
output, and establish the usefulness of central blood volume measurements by PCOM (pediatric
cardiac output measurements), a less invasive procedure

The ability to measure cardiac output accurately and reproducibly at frequent intervals
remains elusive to the clinician caring for critically ill pediatric patients although a
large proportion of these children are known to have hemodynamic compromise as a result of
their illnesses. I propose to define the accuracy of clinician estimates of cardiac output
in these patients and to test the ability of a new device that measures central blood volume
to predict preload in this setting.

I will study 100 patients in two groups. The first group will consist of critically ill
pediatric patients at the time of admission to the PICU. These 50 patients will have cardiac
output estimated by three methods: Estimation by a "panel of experienced clinicians";
Calculation of the arteriovenous content difference; and Direct measurement using a new
minimally invasive system based on assessing changes in ultrasound transmission in blood
after intravenous administration of a small (< 5 ml) bolus of normal saline. Group two will
consist of 50 PICU patients who therapeutically require either a fluid bolus (25 patients)
or a single intravenous dose of diuretic (25 patients). These patients will be assessed in
the same fashion at the outset, but will have ongoing measurements of cardiac output and
central blood volume using the minimally invasive system and central venous pressure using
conventional techniques at 3 intervals within the first hour.

Data will be analyzed to evaluate the strength of correlations between expert assessment and
objective measures of cardiac output in all patients (linear regression with calculation of
correlation coefficient). Group two patients will be divided according to therapeutic
intervention. The strength of correlation between changes in central blood volume and
changes in central venous pressure and cardiac output will be assessed using similar
statistical techniques.

Inclusion Criteria:

- patients less than 16 years of age

- admitted to the PICU after surgery

- indwelling central venous and arterial catheters

- arterial oxygen saturation greater than 94% while breathing 60% oxygen

- ability to draw blood from both arterial and venous catheters

- require fluid bolus or dose of diuretic

- require mechanical ventilation

- no change in dosing of inotropic or vasoactive agents over prior to 60 minutes

Exclusion Criteria:

- hemodynamic instability
We found this trial at
1
site
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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