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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01050361
First received: January 13, 2010
Last updated: January 18, 2011
Last verified: January 2011
  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 ]

Estimated Enrollment: 300
Study Start Date: June 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)
    Duration lasts the entire operation.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050361

Contacts
Contact: Tara R Brakke, M.D. (402) 559-4081 tbrakke@unmc.edu
Contact: Candice R Montzingo, M.D. (402) 559-4081 cmontzin@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Tara R Brakke, MD    402-559-4081    tbrakke@unmc.edu   
Contact: Candace R Montzingo, MD    (402) 559-4081    cmontzin@unmc.edu   
Principal Investigator: Tara MD Brakke, MD         
Sub-Investigator: Sasha Shillcutt, M.D.         
Sub-Investigator: Candice Montzingo, M.D.         
Sub-Investigator: Ankit Agrawal         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Tara R Brakke, MD University of Nebraska
  More Information

No publications provided

Responsible Party: Tara Brakke, M.D. Principal Investigator, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT01050361     History of Changes
Other Study ID Numbers: 321-09-FB
Study First Received: January 13, 2010
Last Updated: January 18, 2011
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 August 28, 2014