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

Conditions

Diastolic Dysfunction

Keywords

Separation, Cardiopulmonary bypass, Calcium chloride

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.

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Interventions

DRUGCalcium Chloride

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

DRUGPlacebo

Normal saline, 50cc delivered over 5 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Diastolic Dysfunction	64 enrolled patients or 9 months following start of protocol, whichever comes first	E/ A ratio on TEE. This ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave) is reflective of degree of diastolic dysfunction.

Secondary

Measure	Time frame	Description
Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability	64 enrolled patients or 9 months following start of protocol, whichever comes first	Return to Cardiopulmonary bypass Yes/ No
Need for Inotropic or Vasopressor Support Upon Leaving the OR	64 enrolled patients or 9 months following start of protocol, whichever comes first	Use of inotropes or vasopressors in the Operating Room.
Length of Hospital Stay (Days)	64 enrolled patients or 9 months following start of protocol, whichever comes first	Hospital length of stay in days.
Length of ICU Stay (Days)	64 enrolled patients or 9 months following start of protocol, whichever comes first	Intensive Care Unit length of stay in days.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Calcium Choloride Calcium chloride, 10mg/kg Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes	4
Placebo Normal saline Placebo: Normal saline, 50cc delivered over 5 minutes	4
Total	8

Baseline characteristics

Characteristic	Calcium Choloride	Placebo	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	4 Participants	4 Participants	8 Participants
Sex: Female, Male Female	1 Participants	1 Participants	2 Participants
Sex: Female, Male Male	3 Participants	3 Participants	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 4	0 / 4
serious Total, serious adverse events	0 / 4	0 / 4

Outcome results

Primary

Diastolic Dysfunction

E/ A ratio on TEE. This ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave) is reflective of degree of diastolic dysfunction.