Study of the Effect of Inhaled Anesthetics on Diastolic Heart Function Using a Doppler-derived Efficiency Index

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00907439
First received: May 20, 2009
Last updated: November 3, 2010
Last verified: November 2010
  Purpose

The purpose of this study is to determine the effect of inhaled anesthetic drugs upon diastolic heart function (heart suction and filling performance) in patients who are undergoing coronary bypass surgery.


Condition
Diastolic Dysfunction
Coronary Artery Disease
General Anesthesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Diastolic Dysfunction With the Onset of Volatile Anesthesia in Patients Undergoing Coronary Artery Bypass Grafting as Determined by a Load-independent Efficiency Index Derived From the Parameterized Doppler Analysis of Left Ventricular Filling

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Diastolic efficiency index (derived from the parameterized analysis of transmitral early filling Doppler using the paradigm of the ventricle as a damped harmonic oscillator) [ Time Frame: Following induction of volatile anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diastolic efficiency index (derived from the parameterized analysis of transmitral early filling Doppler using the paradigm of the ventricle as a damped harmonic oscillator) [ Time Frame: Following the onset of controlled ventilation ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Diastolic heart dysfunction is a significant cause of cardiovascular morbidity and is the cause of symptomatic heart failure in approximately one half of patients who are admitted to hospitals with heart failure symptoms. However, diastolic heart function remains difficult to measure objectively without cardiac catheterization. Diastolic heart dysfunction is also common among patients undergoing coronary bypass grafting (CABG) surgery. Despite the ubiquitous use of inhaled volatile drugs to maintain anesthesia in these patients, their effects upon diastolic heart function remain unclear.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing non-emergent coronary artery bypass grafting surgery at a tertiary care center

Criteria

Inclusion Criteria:

  • Non-emergent coronary bypass grafting surgery
  • Left ventricular ejection fraction of 40% or greater

Exclusion Criteria:

  • Myocardial infarction within 4 weeks
  • Greater than mild cardiac valvular pathology
  • Body mass index greater than 35
  • Cardiac dysrhythmias or pacemaker therapy
  • Left bundle branch block
  • Uncontrolled gastroesophageal reflux disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907439

Locations
United States, Missouri
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Troy S Wildes, MD Washington University School of Medicine, Department of Anesthesiology
  More Information

Publications:
Responsible Party: Troy Wildes, MD, Assistant Professor, Washington University School of Medicine, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00907439     History of Changes
Other Study ID Numbers: WU-HRPO-07-0551
Study First Received: May 20, 2009
Last Updated: November 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Diastole, physiopathology
coronary artery disease
volatile anesthetic
sevoflurane

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014