NCT00955266

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Diastolic Dysfunction

Interventions

Type	Name	Description
DRUG	Calcium Chloride	Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes
DRUG	Placebo	Normal saline, 50cc delivered over 5 minutes

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-08-10
• Last updated: 2017-05-22
• Results posted: 2017-05-22

Locations

1 site across 1 country: United States