Low Cardiac OutputNCT00167440
Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients
An observational study of Low Cardiac Output, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Low Cardiac Output
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children, newborn through age 16 admitted to a pediatric intensive care unit (PICU)
Who may be able to join
- 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
Who cannot join
- hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Low Cardiac Output
- Keywords
- cardiac index, cardiac output, indwelling central venous catheter, indwelling arterial catheter
- Medical subject headings
- Cardiac Output, Low
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Personelle changes mandated suspension.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Cardiac OutputStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, jeffrey rubenstein, University of Rochester
- Investigators
- Jeffrey Rubenstein, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167440
- Sponsor's protocol ID
- 10398
- Other IDs
- 5R44HL06199403
- Status last verified
- Nov 2015
- First submitted
- 9 Sep 2005
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00167440
- Acronym / sponsor ID
- 10398
- Conditions
- Low Cardiac Output
- Keywords
- cardiac index, cardiac output, indwelling central venous catheter, indwelling arterial catheter
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Personelle changes mandated suspension.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children, newborn through age 16 admitted to a pediatric intensive care unit (PICU)
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Rubenstein, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Cardiac Output, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2015.