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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:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00955266
First received: July 30, 2009
Last updated: February 22, 2010
Last verified: February 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Calcium
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Length of hospital stay (days) [ Time Frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first ] [ Designated as safety issue: Yes ]
  • Length of ICU stay (days) [ Time Frame: 64 enrolled patients or 9 months following start of protocol, whichever comes first ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 142
Study Start Date: July 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Calcium Choloride
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women greater than 18 years of age
  • Undergoing primary elective valve surgery at BWH
  • Consented for 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Michael Nurok, MD PhD, Brigham and Womens Hospital
ClinicalTrials.gov Identifier: NCT00955266     History of Changes
Other Study ID Numbers: 2009-P-000052
Study First Received: July 30, 2009
Last Updated: February 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Separation
Cardiopulmonary bypass
Calcium chloride

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

ClinicalTrials.gov processed this record on May 23, 2013