Clinical trial NCT00955266: A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass
Official title: A Randomized Double-Blind Placebo-Controlled Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diastolic Dysfunction
Keywords: Separation
Cardiopulmonary bypass
Calcium chloride
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2009-08-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Diastolic Dysfunction
timeFrame: 64 enrolled patients or 9 months following start of protocol, whichever comes first
Secondary outcomes:
measure: Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability
timeFrame: 64 enrolled patients or 9 months following start of protocol, whichever comes first
measure: Need for Inotropic or Vasopressor Support Upon Leaving the OR
timeFrame: 64 enrolled patients or 9 months following start of protocol, whichever comes first
measure: Length of Hospital Stay (Days)
timeFrame: 64 enrolled patients or 9 months following start of protocol, whichever comes first
measure: Length of ICU Stay (Days)
timeFrame: 64 enrolled patients or 9 months following start of protocol, whichever comes first
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Michael Nurok, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: