PreeclampsiaNCT00465114
Minimally-invasive Assessment of Cardiac Output in Severe Preeclampsia
An observational study of Preeclampsia, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Hemodynamic Monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2007to Dec 2007
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- Severe Preeclampsia
- Arterial Line Required
- Candidates for magnesium sulfate, labetalol or hydrazine
Who cannot join
- Preexisting cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally-invasive Assessment of Cardiac Output in Severe Preeclampsia: Radial Artery Wave Form Analysis Versus Trans-thoracic Echocardiogram
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.
Read the 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.
- Conditions
- Preeclampsia
- Being tested
- Hemodynamic Monitoring
- Keywords
- Preeclampsia, Hemodynamic monitoring
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic MonitoringProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startApr 2007
- Study completionDec 2007 (estimated)
Why it stopped: Feasibility issues, only 1 patient recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- 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
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jose CA Carvalho, MD PhD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465114
- Sponsor's protocol ID
- 07-06
- Other IDs
- 07-0078-E
- Status last verified
- Feb 2018
- First submitted
- 23 Apr 2007
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally-invasive Assessment of Cardiac Output in Severe Preeclampsia: Radial Artery Wave Form Analysis Versus Trans-thoracic Echocardiogram
- ClinicalTrials.gov ID
- NCT00465114
- Acronym / sponsor ID
- 07-06
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Hemodynamic monitoring
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Feasibility issues, only 1 patient recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 24 Apr 2007 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (3 listed)
- Severe Preeclampsia
- Arterial Line Required
- Candidates for magnesium sulfate, labetalol or hydrazine
Key exclusion criteria (1 listed)
- Preexisting cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodynamic Monitoring | Procedure or surgery | – |
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 6 Feb 2018.
Related trials for Preeclampsia
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Jose CA Carvalho, MD PhD principal investigator
MOUNT SINAI HOSPITAL
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 Preeclampsia, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 3 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 6 Feb 2018. 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 Canada. 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 6 Feb 2018.