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NCT01050361 · ClinicalTrials.gov registry record · NA

Echocardiography Management for Patients Requiring Care for Non-Cardiac Surgery

A NA study, sponsored by University of Nebraska.

Completed
Registry status
NA
Development phase
35
Enrollment target

NCT01050361: Completed NA study, sponsored by University of Nebraska.

NCT01050361 is a NA study that has completed, run by University of Nebraska. The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01050361, a NA study, has completed, sponsored by University of Nebraska.

COMPLETED
Registry status
NA
Development phase
35 participants
Enrollment target

Study Summary

The growing population of institution 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

Primary Outcome

Obtain standard cardiac ultrasound-generated data points \[Parasternal Long Axis, Parasternal Short Axis, Apical 4 Chamber, Subxiphoid (Subcostal), and inferior vena cava (IVC) views\] to manage, modify, and optimize the participant cardiac preload, afterload, heart rate and contractility in the perioperative period.

Interventions

  • PROCEDURE Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2010-07-28
Est. Completion 2013-01-09
Phase NA
University of Nebraska

407 total trials

What the finished NCT01050361 record still lists

NCT01050361 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE) is the first listed.

NCT01050361 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01050361 about?

NCT01050361 is a clinical study titled "Echocardiography Management for Patients Requiring Care for Non-Cardiac Surgery". The growing population of institution 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 su...

What is the current status of trial NCT01050361?

This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2010-07-28. Estimated completion is 2013-01-09.

What interventions are being tested in trial NCT01050361?

The interventions under investigation include: Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE) (PROCEDURE).

Who is sponsoring clinical trial NCT01050361?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01050361's enrollment target sits among peer trials

35 1564th of 2000 higher than 431 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01050361, the US trial registry maintained by the National Library of Medicine. NCT01050361 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.