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

Mass General Brigham

Status and phase

Terminated

Phase 4

Conditions

Diastolic Dysfunction

Treatments

Drug: Placebo

Drug: Calcium Chloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00955266

2009-P-000052

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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