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

This study has been terminated.
(Personelle changes mandated suspension.)
Sponsor:
Collaborator:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00167440
First received: September 9, 2005
Last updated: July 8, 2008
Last verified: July 2008
  Purpose

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


Condition Phase
Low Cardiac Output
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Estimated Enrollment: 100
Study Start Date: August 2004
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children, newborn through age 16 admitted to a pediatric intensive care unit (PICU)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167440

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Jeffrey Rubenstein, MD University of Rochester
  More Information

No publications provided

Responsible Party: Jeffrey Rubenstein, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT00167440     History of Changes
Other Study ID Numbers: 10398, 5R44HL06199403
Study First Received: September 9, 2005
Last Updated: July 8, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
cardiac index
cardiac output
indwelling central venous catheter
indwelling arterial catheter

Additional relevant MeSH terms:
Critical Illness
Cardiac Output, Low
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014