A Phase 4 interventional study of Calcium Chloride and Placebo in Diastolic Dysfunction, sponsored by Brigham and Women's Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-22.
Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Prevention
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.
Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Calcium chloride, 10mg/kg
Drug: Calcium Chloride
Normal saline
Drug: Placebo
Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes
Normal saline, 50cc delivered over 5 minutes
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.
Time frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first
Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability
Return to Cardiopulmonary bypass Yes/ No
Time frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first
Need for Inotropic or Vasopressor Support Upon Leaving the OR
Use of inotropes or vasopressors in the Operating Room.
Time frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first
Length of Hospital Stay (Days)
Hospital length of stay in days.
Time frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first
Length of ICU Stay (Days)
Intensive Care Unit length of stay in days.
Time frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first
| Milestone | Calcium Choloride | Placebo |
|---|---|---|
| Started | 4 | 4 |
| Completed | 4 | 4 |
| Not completed | 0 | 0 |
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.
| Measure | Calcium Choloride | Placebo |
|---|---|---|
| Diastolic Dysfunction | 0 | 0 |
Return to Cardiopulmonary bypass Yes/ No
| Measure | Calcium Choloride | Placebo |
|---|---|---|
| Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability | 0 | 0 |
Use of inotropes or vasopressors in the Operating Room.
| Measure | Calcium Choloride | Placebo |
|---|---|---|
| Need for Inotropic or Vasopressor Support Upon Leaving the OR | 0 | 0 |
Hospital length of stay in days.
| Measure | Calcium Choloride | Placebo |
|---|---|---|
| Length of Hospital Stay (Days) | 0 | 0 |
Intensive Care Unit length of stay in days.
| Measure | Calcium Choloride | Placebo |
|---|---|---|
| Length of ICU Stay (Days) | 0 | 0 |
Collected over 1 year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Calcium Choloride | — | 0/4 (0%) | 0/4 (0%) |
| Placebo | — | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Calcium Choloride | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 4 | 8 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Calcium Choloride | Placebo | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 3 | 3 | 6 |
This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital