A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass

Study Overview
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Brief Summary
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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 usually gives calcium to people when they come off of the heart and lung machine because some doctors believe that calcium can jump start the heart. Not every hospital does this. Some people think that calcium may have a side effect of making the heart more stiff. Stiff hearts do not beat as well or receive as much blood to tissues as non-stiff hearts. If calcium makes the heart stiff, then doctors may have to use other medicines to support the heart in the operating room and the intensive care unit. This may ultimately lead to poorer outcomes including a longer stay in the intensive care unit and in the hospital. This study is being performed to find out if calcium has the side effect of making the heart more stiff. This study compares calcium to placebo. The placebo looks exactly like the calcium, but it contains no calcium. During this study patients may receive placebo instead of calcium. Neither the doctor nor the study team will know which drug the subject will receive.

Official Title
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A Randomized Double-Blind Placebo-Controlled Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass

Conditions
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Diastolic Dysfunction

Intervention / Treatment
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* Drug: Calcium Chloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calcium Chloride<br>Calcium chloride, 10mg/kg | Drug: Calcium Chloride<br>* Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes<br>|
| Placebo Comparator: Placebo<br>Normal saline | Drug: Placebo<br>* Normal saline, 50cc delivered over 5 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Dysfunction | E/ A ratio on TEE. This ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave) is reflective of degree of diastolic dysfunction. | 64 enrolled patients or 9 months following start of protocol, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability | Return to Cardiopulmonary bypass Yes/ No | 64 enrolled patients or 9 months following start of protocol, whichever comes first | 
| Need for Inotropic or Vasopressor Support Upon Leaving the OR | Use of inotropes or vasopressors in the Operating Room. | 64 enrolled patients or 9 months following start of protocol, whichever comes first | 
| Length of Hospital Stay (Days) | Hospital length of stay in days. | 64 enrolled patients or 9 months following start of protocol, whichever comes first | 
| Length of ICU Stay (Days) | Intensive Care Unit length of stay in days. | 64 enrolled patients or 9 months following start of protocol, whichever comes first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Separation, Cardiopulmonary bypass, Calcium chloride