Diastolic DysfunctionPhase 4NCT00955266
A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass
A Phase 4 study testing Calcium Chloride in people with Diastolic Dysfunction, run by Brigham and Women's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diastolic Dysfunction
- What is being tested?
- Calcium Chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Feb 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Womens Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Randomized Double-Blind Placebo-Controlled 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 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.
- Conditions
- Diastolic Dysfunction
- Being tested
- Calcium Chloride, Placebo
- Keywords
- Separation, Cardiopulmonary bypass, Calcium chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium ChlorideDrug
Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes
PlaceboDrug
Normal saline, 50cc delivered over 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Calcium Chloride | Active comparator | Calcium chloride, 10mg/kg Receives: Drug: Calcium Chloride |
| Placebo | Placebo comparator | Normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 64 enrolled patients or 9 months following start of protocol, whichever comes first
Secondary outcomes (4)
Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability
Return to Cardiopulmonary bypass Yes/ No
Measured: 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.
Measured: 64 enrolled patients or 9 months following start of protocol, whichever comes first
Length of Hospital Stay (Days)
Hospital length of stay in days.
Measured: 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.
Measured: 64 enrolled patients or 9 months following start of protocol, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Nurok, MD, PhD, Brigham and Women's Hospital
- Investigators
- Michael Nurok, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955266
- Sponsor's protocol ID
- 2009-P-000052
- Status last verified
- Apr 2017
- First submitted
- 30 Jul 2009
- Last updated
- 22 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-Controlled Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00955266
- Acronym / sponsor ID
- 2009-P-000052
- Conditions
- Diastolic Dysfunction
- Keywords
- Separation, Cardiopulmonary bypass, Calcium chloride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Posted 22 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Chloride | Active comparator | Drug: Calcium ChlorideCalcium chloride, 10mg/kg |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium ChlorideCalcium chloride 10mg/kg in 50cc NS delivered over 5 minutes | Drug | Calcium Chloride |
| PlaceboNormal saline, 50cc delivered over 5 minutes | Drug | Placebo |
Primary outcome
Diastolic Dysfunction
Time frame: 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.
4 secondary outcomes
Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability
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
Time frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first
Length of Hospital Stay (Days)
Time frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first
Length of ICU Stay (Days)
Time frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Nurok, MD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium Chloride in people with Diastolic Dysfunction, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic Dysfunction (time frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.