Overview

Conditions ventricular dysfunction, left, major adverse cardiac events
Treatment eghem
Phase phase 1
Sponsor University of Nebraska
Start date September 2014
End date May 2017
Trial size 120 participants
Trial identifier NCT01780727, 630-12-FB

Summary

Elderly patients are the fastest growing surgical population and present with increased risk of postoperative cardiac problems, especially congestive heart failure. Diastolic dysfunction is common in the elderly population and increases the risk of major adverse cardiac events after surgery. This project will use dynamic measurements of diastolic filling pressures by echocardiography for goal-directed fluid and drug management during surgery to determine whether this reduces serious cardiac events related to diastolic dysfunction after surgery in this high-risk population.

Recruiting in the following locations…

United States Nebraska
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
use of standard hemodynamic management
(Experimental)
use of echocardiography guided hemodynamic management to control fluid and drug therapy.
eghem
Echocardiography guided hemodynamic management. Subjects in this arm will undergo intraoperative transesophageal echocardiography as part of the study.

Primary Outcomes

Measure
Number of Patients who undergo dynamic heart function changes during surgery
time frame: 2 years

Secondary Outcomes

Measure
Safety of Echo-Guided Hemodynamic Management during surgery
time frame: 1 year

Eligibility Criteria

Male or female participants at least 70 years old.

Inclusion Criteria: - Age 70 years and older - Echocardiographic Evidence of Grade I, II or III LVDD on Preoperative Transthoracic Echocardiography (TTE) examination - Undergoing Vascular Surgery including but not limited to : Lower extremity bypass,Open abdominal aortic aneurysm repair Exclusion Criteria: - Patients with expected hospital stay < 24 hours - Inability to undergo TEE and Transesophageal Echocardiography(TTE) - Clinical evidence/suspicion of elevated Intercranial Pressure (ICP) - Preoperative shock or systemic sepsis - Emergency operation - American Society of Anesthesiologists Status V - Participation in another clinical trial - General Anesthesia not planned for procedure

Additional Information

Official title Echocardiography-guided Hemodynamic (EGHEM) Management Strategy to Improve Clinical Outcomes for Elderly Patients With Left Ventricular Diastolic Dysfunction (LVDD) Undergoing Non-cardiac Surgery
Principal investigator Sasha K Shillcutt, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Nebraska.