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

NCT ID: NCT00955266

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-02-28

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.

Conditions

Diastolic Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Calcium Chloride

Calcium chloride, 10mg/kg

Group Type: ACTIVE_COMPARATOR

Calcium Chloride

Intervention Type: DRUG

Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes

Placebo

Normal saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline, 50cc delivered over 5 minutes

Interventions

Calcium Chloride

Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes

Intervention Type: DRUG

Placebo

Normal saline, 50cc delivered over 5 minutes

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael Nurok, MD, PhD

Cardiac Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Nurok, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Womens Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2009-P-000052

Identifier Type: -

Identifier Source: org_study_id