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Minimally-invasive Assessment of Cardiac Output in Severe Preeclampsia

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ClinicalTrials.gov Identifier: NCT00465114
Recruitment Status : Withdrawn (Feasibility issues, only 1 patient recruited.)
First Posted : April 24, 2007
Last Update Posted : October 5, 2009
Information provided by:

Study Description
Brief Summary:

Severe preeclampsia often presents with uncontrolled hypertension and therefore requires close monitoring of blood pressure and cardiac performance.

The purpose of the study is to compare two methods of measuring the performance of the heart in pregnant women: one by ultrasound of the heart, the other by assessing the pulse generated in the blood vessel of the wrist. We hope that the method using pulse analysis will be as effective as ultrasound, which is labour intensive and operator dependant.

Condition or disease Intervention/treatment
Preeclampsia Procedure: Hemodynamic Monitoring

Detailed Description:

Severe preeclampsia often presents with uncontrolled hypertension, which requires close monitoring of blood pressure and cardiac output. It will be very useful to know the cardiac output in this patient population, because it will guide the choice of antihypertensive drugs and measure their effect on cardiac output.

Traditionally pulmonary artery catheters were used to measure cardiac output. There are numerous problems with using this method in severe preeclampsia. These include technical difficulty inserting the catheter in an awake, edematous pregnant patient, potentially causing a pneumothorax, damaging the carotid artery or insertion site infection. There is also an increased risk for cardiac arrhythmias. Apart from the risks, the accuracy of the thermodilution measurements can be influenced by factors such as timing of the injection within the respiratory cycle, temperature of the injectate, speed of injection, and placement of the catheter. A readily available, accurate non-invasive cardiac output measurement technique, that will provide reliable data with fewer risks, is needed.

Doppler ultrasound (trans thoracic echocardiography) is the gold standard for measuring cardiac output non-invasively in pregnant patients. Unfortunately the method is operator dependant, not continuous and not always available when needed most.

Recently a device called the FloTrac has been introduced that measures cardiac output minimally invasively. Attached to an arterial line it measures cardiac output every 20 seconds via arterial waveform analysis. The standard of care for measuring blood pressure in severe preeclampsia requires the placement of an intra-arterial line. This group of patients is therefore ideal for measuring cardiac output with the FloTrac, especially since powerful intravenous anti-hypertensives are used to control blood pressure.

Our hypothesis is that the FloTrac will be comparable to Doppler Ultrasound for measuring cardiac output in severely preeclamptic patients.

Study Design

Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Minimally-invasive Assessment of Cardiac Output in Severe Preeclampsia: Radial Artery Wave Form Analysis Versus Trans-thoracic Echocardiogram
Study Start Date : April 2007
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary Care Clinic

Inclusion Criteria:

  • Severe Preeclampsia
  • Arterial Line Required
  • Candidates for magnesium sulfate, labetalol or hydrazine

Exclusion Criteria:

  • Preexisting cardiac disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465114

Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Principal Investigator: Jose CA Carvalho, MD PhD Mount Sinai Hospital, New York
More Information

ClinicalTrials.gov Identifier: NCT00465114     History of Changes
Other Study ID Numbers: 07-06
First Posted: April 24, 2007    Key Record Dates
Last Update Posted: October 5, 2009
Last Verified: October 2009

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Hemodynamic monitoring

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications