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NCT00955266 · ClinicalTrials.gov registry record · Phase 4
A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
NCT00955266: Clinical Trial Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT00955266 is a Phase 4 study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 8 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00955266, a Phase 4 study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Calcium Chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2009-07 |
| Est. Completion | 2010-02 |
| Phase | Phase 4 |
Why NCT00955266 stopped before completion
NCT00955266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00955266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00955266 about?
NCT00955266 is a clinical study titled "A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass". 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 docto...
What is the current status of trial NCT00955266?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2009-07. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00955266?
The interventions under investigation include: Placebo (DRUG), Calcium Chloride (DRUG).
Who is sponsoring clinical trial NCT00955266?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00955266's enrollment target sits among peer trials
8 1972nd of 2000 higher than 20 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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