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

Diastolic Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00955266
• Other study ID #: 2009-P-000052
• Status: Terminated
• Phase: Phase 4
• First received: July 30, 2009
• Last updated: July 15, 2014
• Start date: July 2009
• Est. completion date: February 2010

Study information

• Verified date: July 2014
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diastolic Dysfunction

Intervention

Drug:
• Calcium Chloride
Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes
• Placebo
Normal saline, 50cc delivered over 5 minutes

Locations

Country	Name	City	State
United States	Brigham and Womens Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diastolic dysfunction		64 enrolled patients or 9 months following start of protocol, whichever comes first	Yes
Secondary	Return to cardiopulmonary bypass secondary to hemodynamic instability		64 enrolled patients or 9 months following start of protocol, whichever comes first	Yes
Secondary	Need for inotropic or vasopressor support upon leaving the OR		64 enrolled patients or 9 months following start of protocol, whichever comes first	Yes
Secondary	Length of hospital stay (days)		64 enrolled patients or 9 months following start of protocol, whichever comes first	Yes
Secondary	Length of ICU stay (days)		64 enrolled patients or 9 months following start of protocol, whichever comes first	Yes