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

NCT00955266 | Terminated Phase 4 Results DMC

• 1 other identifier: 2009-P-000052
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diastolic Dysfunction

Keywords

Separation; Cardiopulmonary bypass; Calcium chloride

Outcome Measures

Primary Outcomes (1)

• 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.

  64 enrolled patients or 9 months following start of protocol, whichever comes first

Secondary Outcomes (4)

• Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability

  64 enrolled patients or 9 months following start of protocol, whichever comes first

• Need for Inotropic or Vasopressor Support Upon Leaving the OR

  64 enrolled patients or 9 months following start of protocol, whichever comes first

• Length of Hospital Stay (Days)

  64 enrolled patients or 9 months following start of protocol, whichever comes first

• Length of ICU Stay (Days)

  64 enrolled patients or 9 months following start of protocol, whichever comes first

Study Arms (2)

Calcium Chloride

ACTIVE COMPARATOR

Calcium chloride, 10mg/kg

Drug: Calcium Chloride

Placebo

PLACEBO COMPARATOR

Normal saline

Drug: Placebo

Interventions

Calcium Chloride DRUG

Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes

Calcium Chloride

Placebo DRUG

Normal saline, 50cc delivered over 5 minutes

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Calcium Chloride

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds

Limitations and Caveats

Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised contents of location need to be destroyed. As a result, data is not available for results reporting.

Results Point of Contact

• Title: Michael Nurok
• Organization: Brigham & Women's Hospital

mnurok@gmail.com

617-899-5961

Study Officials

• Michael Nurok, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Anesthesiologist

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: August 10, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: May 22, 2017
• Results First Posted: May 22, 2017

Record last verified: 2017-04

Locations

US (1)