Echo-guided Hemodynamic Management Strategy in Elderly Patients Undergoing Noncardiac Surgery

NCT01780727 | Completed DMC

• 1 other identifier: 0630-12-FB
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly patients are the fastest growing surgical population and have an increased risk of postoperative cardiac problems. Diastolic dysfunction, or the reduced ability of the heart' s ventricles to fill completely, is common in the elderly population and increases the risk of major adverse cardiac events after surgery. This study will measure diastolic filling and implement 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.

Conditions

Ventricular Dysfunction, Left; Major Adverse Cardiac Events

Keywords

echocardiography; hemodynamic management

Outcome Measures

Primary Outcomes (1)

• Number of Patients who undergo dynamic heart function changes during surgery

  We will test the hypothesis that Left Ventricular Diastolic Dysfunction (LVDD) undergoes dynamic changes perioperatively. A. We will preoperatively identify 200 elderly subjects to provide 80% power to detect a change in LVDD undergoing noncardiac surgery using a 0.01 level two-sided paired t-test. B. We will assess changes in LVDD in these subjects based on hourly intraoperative echocardiography data points.

  2 years

Secondary Outcomes (1)

• Safety of Echo-Guided Hemodynamic Management during surgery

  1 year

Study Arms (2)

Standard Hemodynamic Management (SHEM)

NO INTERVENTION

use of standard hemodynamic management

EGHEM

EXPERIMENTAL

use of echocardiography guided hemodynamic management to control fluid and drug therapy.

Procedure: EGHEM

Interventions

EGHEM PROCEDURE

Echocardiography guided hemodynamic management. Subjects in this arm will undergo intraoperative transesophageal echocardiography as part of the study.

EGHEM

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases

Study Officials

• Sasha K Shillcutt, MD

  UNMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1 receives normal saline per the standard of care determined by the anesthesiologist. Arm 2 receives normal saline or furosemide per the results of the intraoperative echocardiogram.

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 31, 2013
• Study Start: September 1, 2014
• Primary Completion: May 31, 2018
• Study Completion: August 27, 2018
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

US (1)