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Inadequate recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Chloride | Active Comparator | Calcium chloride, 10mg/kg |
|
| Placebo | Placebo Comparator | Normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Chloride | Drug | Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Nurok, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcium Choloride | Calcium chloride, 10mg/kg Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes |
| FG001 | Placebo | Normal saline Placebo: Normal saline, 50cc delivered over 5 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcium Choloride | Calcium chloride, 10mg/kg Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes |
| BG001 | Placebo | Normal saline Placebo: Normal saline, 50cc delivered over 5 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting. | Posted | 64 enrolled patients or 9 months following start of protocol, whichever comes first |
|
1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcium Choloride | Calcium chloride, 10mg/kg Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes |
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Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised contents of location need to be destroyed. As a result, data is not available for results reporting.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Nurok | Brigham & Women's Hospital | 617-899-5961 | mnurok@gmail.com |
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| ID | Term |
|---|---|
| D002122 | Calcium Chloride |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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| Placebo |
| Drug |
Normal saline, 50cc delivered over 5 minutes |
|
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo |
Normal saline Placebo: Normal saline, 50cc delivered over 5 minutes |
|
|
| Secondary | Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability | Return to Cardiopulmonary bypass Yes/ No | Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting. | Posted | 64 enrolled patients or 9 months following start of protocol, whichever comes first |
|
|
|
| Secondary | Need for Inotropic or Vasopressor Support Upon Leaving the OR | Use of inotropes or vasopressors in the Operating Room. | Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting. | Posted | 64 enrolled patients or 9 months following start of protocol, whichever comes first |
|
|
|
| Secondary | Length of Hospital Stay (Days) | Hospital length of stay in days. | Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting. | Posted | 64 enrolled patients or 9 months following start of protocol, whichever comes first |
|
|
|
| Secondary | Length of ICU Stay (Days) | Intensive Care Unit length of stay in days. | Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting. | Posted | 64 enrolled patients or 9 months following start of protocol, whichever comes first |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Placebo | Normal saline Placebo: Normal saline, 50cc delivered over 5 minutes | 0 | 4 | 0 | 4 |
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| D017606 |
| Chlorine Compounds |