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

NCT00167440 | Withdrawn

• 2 other identifiers: 103985R44HL06199403
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Cardiac Output

Keywords

cardiac index; cardiac output; indwelling central venous catheter; indwelling arterial catheter

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• hemodynamic instability

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Rubenstein, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: August 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 26, 2015

Record last verified: 2015-11

Locations

US (1)