A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass
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|ClinicalTrials.gov Identifier: NCT00955266|
Recruitment Status : Terminated (Inadequate recruitment)
First Posted : August 10, 2009
Results First Posted : May 22, 2017
Last Update Posted : May 22, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Diastolic Dysfunction||Drug: Calcium Chloride Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Double-Blind Placebo-Controlled Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Active Comparator: Calcium Chloride
Calcium chloride, 10mg/kg
Drug: Calcium Chloride
Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes
Placebo Comparator: Placebo
Normal saline, 50cc delivered over 5 minutes
- Diastolic Dysfunction [ Time Frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first ]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.
- Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability [ Time Frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first ]Return to Cardiopulmonary bypass Yes/ No
- Need for Inotropic or Vasopressor Support Upon Leaving the OR [ Time Frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first ]Use of inotropes or vasopressors in the Operating Room.
- Length of Hospital Stay (Days) [ Time Frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first ]Hospital length of stay in days.
- Length of ICU Stay (Days) [ Time Frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first ]Intensive Care Unit length of stay in days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955266
|United States, Massachusetts|
|Brigham and Womens Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Michael Nurok, MD, PhD||Brigham and Women's Hospital|