Minimally-invasive Assessment of Cardiac Output in Severe Preeclampsia

This study has been withdrawn prior to enrollment.
(Feasibility issues, only 1 patient recruited.)
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00465114
First received: April 23, 2007
Last updated: October 1, 2009
Last verified: October 2009
  Purpose

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 Intervention
Preeclampsia
Procedure: Hemodynamic Monitoring

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Estimated Enrollment: 12
Study Start Date: April 2007
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary Care Clinic

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Preexisting cardiac disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00465114

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

No publications provided

ClinicalTrials.gov Identifier: NCT00465114     History of Changes
Other Study ID Numbers: 07-06, 07-0078-E
Study First Received: April 23, 2007
Last Updated: October 1, 2009
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014