Echocardiography Management for Patients Requiring Care for Non-Cardiac Surgery (EGHEM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tara Brakke MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01050361
First received: January 13, 2010
Last updated: May 16, 2016
Last verified: May 2016
  Purpose
The growing population of University of Nebraska Medical Center patients with heart failure combined with the increasing number of surgical procedures performed each year supports the need for a critical analysis of how to most appropriately manage these patients during the perioperative period, especially for non-cardiac surgery. Echo-guided hemodynamic management (EGHEM) is the use of echocardiography data to normalize and/or optimize in real-time, cardiac output and ventricular filling pressures in the perioperative period for non-cardiac surgical cases. The purpose of this study is to test the hypothesis that EGHEM compared to standard management practices will result in a reduced length of hospital stay in the noncardiac surgery population. The primary goal of health care providers for patients requiring anesthetic care, perioperative care, or critical care is ensuring the adequacy of the patient's circulatory function by optimizing cardiac output and ventricular filling pressure. Currently, the use of the ECG monitor and systemic blood pressure are the standard of care for assessing circulatory function. However, those data cannot provide accurate information on cardiac output and ventricular filling pressure for patients with cardiovascular risk factors and/or comorbidities. As a result, managing the hemodynamic parameters of these patients, as well as their intravenous fluid needs and resuscitation strategy, we hypothesize that using traditional approaches may lead to significant volume overload and post-operative cardiovascular complications and morbidity. In this study we propose an EGHEM strategy that incorporates standard echocardiography generated data points in addition to the systemic blood pressure and ECG signal to assess, manage, modify and optimize patient cardiac preload, afterload, heart rate and contractility in the perioperative period. Based on our initial observations and preliminary data using the EGHEM approach, we hypothesize that we can demonstrate a significant decrease in hospital length of stay and an overall decrease in perioperative morbidity at 30 days in the non-cardiac surgery population using EGHEM compared to standard practices. In this proposal we have designed a single center, prospective, randomized clinical trial to test our hypothesis.

Condition Intervention Phase
Cardiovascular Risk Factors
Procedure: Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Echocardiography-Guided Hemodynamic Management Strategy for Patients Requiring Perioperative Care for Non-Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • To use standard cardiac ultrasound-generated data points in addition to systemic blood pressure and ECG signal to assess, manage, modify, and optimize the patient cardiac preload, afterload, heart rate and contractility in the perioperative period. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • To reduce perioperative morbidity and mortality associated with congestive heart failure for non-cardiac surgeries. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To evaluate and support the conclusion that echocardiography is a superior technology for identifying these changes and managing the unique cardiovascular challenges of the UNMC patient population. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: June 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGHEM
The intervention group will be called EGHEM - Echo Guided HEmodyanmic Management - and will receive their intraoperative maintenance fluid and possible drug therapy (furosemide) based on their hourly intraoperative LVDD grade.
Procedure: Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)
Duration lasts the entire operation.
No Intervention: SHEM

The control group will be

called SHEM - Standard HEmodynamic Management - and will NOT receive the study intervention, but will receive standard anesthesia and hemodynamic management based on current standards within the institution.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 100 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥ 65 years
  2. Hypertension (HTN)
  3. Diabetes
  4. Obesity (body mass index [BMI] >35)
  5. Renal insufficiency
  6. Tobacco usage
  7. Hypercholesterolemia
  8. Sleep apnea/heavy snoring at night
  9. Clinical diagnosis of CHF as defined by:

    1. Dyspnea on exertion
    2. Paroxysmal nocturnal dyspnea
    3. Orthopnea
    4. Elevated jugular venous pressure
    5. Pulmonary rales
    6. Third heart sound
    7. Cardiomegaly or pulmonary edema on chest x-ray
    8. Peripheral edema
    9. Hepatomegaly
    10. Pleural effusion
  10. Palpitations/irregular heart beats
  11. Chest pain at rest and or exercise
  12. Murmur on examination
  13. Known coronary artery disease (CAD)/stents/coronary artery bypass graft (CABG)
  14. Known valvular disease
  15. Known stroke or transient ischemic attacks (TIA)

Exclusion Criteria:

  1. Patients expected to say in the hospital for less than 24 hours.
  2. Inability of undergo TEE and TTE
  3. Clinical evidence or suspicion of elevated intracranial pressure.
  4. Preoperative shock or systemic sepsis
  5. Emergency Operation
  6. ASA Class V
  7. Inability of give informed consent
  8. Participation in another clinical trial
  9. Prisoner
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01050361

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Tara R Brakke, MD University of Nebraska
  More Information

Responsible Party: Tara Brakke MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01050361     History of Changes
Other Study ID Numbers: 321-09-FB 
Study First Received: January 13, 2010
Last Updated: May 16, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
To reduce perioperative morbidity and mortality associated with congestive heart failure for non-cardiac surgeries

ClinicalTrials.gov processed this record on May 26, 2016