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

April 10, 2017 updated by: Michael Nurok, MD, PhD, Brigham and Women's Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Womens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Normal saline
Drug: Placebo
Normal saline, 50cc delivered over 5 minutes
ACTIVE_COMPARATOR: Calcium Chloride
Calcium chloride, 10mg/kg
Drug: Calcium Chloride
Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
64 enrolled patients or 9 months following start of protocol, whichever comes first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Use of inotropes or vasopressors in the Operating Room.
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
Hospital length of stay in days.
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
Intensive Care Unit length of stay in days.
64 enrolled patients or 9 months following start of protocol, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Michael Nurok, MD, PhD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

July 30, 2009

First Submitted That Met QC Criteria

August 6, 2009

First Posted (ESTIMATE)

August 10, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 22, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-P-000052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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