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

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diastolic Dysfunction

Intervention: Calcium Chloride (Drug); Placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Brigham and Women's Hospital

Official(s) and/or principal investigator(s):
Michael Nurok, MD, PhD, Principal Investigator, Affiliation: Brigham and Women's Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Diastolic dysfunction

Secondary outcome:

Return to cardiopulmonary bypass secondary to hemodynamic instability

Need for inotropic or vasopressor support upon leaving the OR

Length of hospital stay (days)

Length of ICU stay (days)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women greater than 18 years of age

- Undergoing primary elective valve surgery at BWH

- Consented for 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

Locations and Contacts

Brigham and Womens Hospital, Boston, Massachusetts 02115, United States
Additional Information

Starting date: July 2009
Last updated: July 15, 2014

Page last updated: August 20, 2015

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