Echocardiography Management for Patients Requiring Care for Non-Cardiac Surgery (EGHEM)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01050361 |
Recruitment Status
:
Completed
First Posted
: January 15, 2010
Last Update Posted
: May 17, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Risk Factors | Procedure: Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE) | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Echocardiography-Guided Hemodynamic Management Strategy for Patients Requiring Perioperative Care for Non-Cardiac Surgery |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |
Arm | Intervention/treatment |
---|---|
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. |
- 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 ]
- To reduce perioperative morbidity and mortality associated with congestive heart failure for non-cardiac surgeries. [ Time Frame: 3 years ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years to 100 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age ≥ 65 years
- Hypertension (HTN)
- Diabetes
- Obesity (body mass index [BMI] >35)
- Renal insufficiency
- Tobacco usage
- Hypercholesterolemia
- Sleep apnea/heavy snoring at night
-
Clinical diagnosis of CHF as defined by:
- Dyspnea on exertion
- Paroxysmal nocturnal dyspnea
- Orthopnea
- Elevated jugular venous pressure
- Pulmonary rales
- Third heart sound
- Cardiomegaly or pulmonary edema on chest x-ray
- Peripheral edema
- Hepatomegaly
- Pleural effusion
- Palpitations/irregular heart beats
- Chest pain at rest and or exercise
- Murmur on examination
- Known coronary artery disease (CAD)/stents/coronary artery bypass graft (CABG)
- Known valvular disease
- Known stroke or transient ischemic attacks (TIA)
Exclusion Criteria:
- Patients expected to say in the hospital for less than 24 hours.
- Inability of undergo TEE and TTE
- Clinical evidence or suspicion of elevated intracranial pressure.
- Preoperative shock or systemic sepsis
- Emergency Operation
- ASA Class V
- Inability of give informed consent
- Participation in another clinical trial
- Prisoner

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050361
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 |
Principal Investigator: | Tara R Brakke, MD | University of Nebraska |
Responsible Party: | Tara Brakke MD, Principal Investigator, University of Nebraska |
ClinicalTrials.gov Identifier: | NCT01050361 History of Changes |
Other Study ID Numbers: |
321-09-FB |
First Posted: | January 15, 2010 Key Record Dates |
Last Update Posted: | May 17, 2016 |
Last Verified: | May 2016 |
Keywords provided by Tara Brakke MD, University of Nebraska:
To reduce perioperative morbidity and mortality associated with congestive heart failure for non-cardiac surgeries |