Status:
TERMINATED
A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Diastolic Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Successful heart surgery requires the resumption of a strong beating heart prior to separation from the heart and lung machine. There are different ways to do this. At this hospital, the surgical team...
Eligibility Criteria
Inclusion
- Men and women greater than 18 years of age
- Undergoing primary elective valve surgery at Brigham and Women's Hospital
- Consented for Transesophogeal Echocardiography (TEE) as part of routine intra-operative care and monitoring
Exclusion
- Patients not consented for TEE as part of routine intra-operative care
- Any absolute contraindication to TEE
- Ionized calcium level \< 0.80 mmol/L near separation from CPB
- Myocardial infarction (MI) or acute coronary syndromes \< 3 months prior to surgery due to the presence of pre-operative diastolic dysfunction in infarcted or ischemic myocardium
- Ejection fraction (EF) \< 35%
- Atrial fibrillation / flutter the absence of an A wave on mitral inflow Doppler
- Heart rate (HR) \> 100 during 2 data point collections due to E / A wave superimposition
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00955266
Start Date
July 1 2009
End Date
February 1 2010
Last Update
May 22 2017
Active Locations (1)
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1
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115