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

This study has been terminated.
(Inadequate recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00955266
First Posted: August 10, 2009
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Nurok, MD, PhD, Brigham and Women's Hospital
  Purpose

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.


Condition Intervention Phase
Diastolic Dysfunction Drug: Calcium Chloride Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Double-Blind Placebo-Controlled Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Michael Nurok, MD, PhD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first ]
    Hospital length of stay in days.

  • Length of ICU Stay (Days) [ Time Frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first ]
    Intensive Care Unit length of stay in days.


Enrollment: 8
Study Start Date: July 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Calcium Chloride
Calcium chloride, 10mg/kg
Drug: Calcium Chloride
Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes
Placebo Comparator: Placebo
Normal saline
Drug: Placebo
Normal saline, 50cc delivered over 5 minutes

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955266


Locations
United States, Massachusetts
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Michael Nurok, MD, PhD Brigham and Women's Hospital
  More Information

Responsible Party: Michael Nurok, MD, PhD, Cardiac Anesthesiologist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00955266     History of Changes
Other Study ID Numbers: 2009-P-000052
First Submitted: July 30, 2009
First Posted: August 10, 2009
Results First Submitted: January 27, 2017
Results First Posted: May 22, 2017
Last Update Posted: May 22, 2017
Last Verified: April 2017

Keywords provided by Michael Nurok, MD, PhD, Brigham and Women's Hospital:
Separation
Cardiopulmonary bypass
Calcium chloride

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs