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NCT04458701 · ClinicalTrials.gov registry record

Prospective Data Analysis of a Quality Improvement Initiative in High Risk Cardiac Surgery Patients

A clinical trial, sponsored by Loma Linda University.

Completed
Registry status
195
Enrollment target

NCT04458701 is a clinical trial that has completed, run by Loma Linda University. The registered enrollment target is 195 participants.

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The verdict

NCT04458701 has completed, sponsored by Loma Linda University.

COMPLETED
Registry status
195 participants
Enrollment target

Study Summary

This project is designed to assess the impact of implementing a hemodynamic optimization protocol, utilizing flow guided parameters that is provided by technology from Edwards Lifesciences, for patients undergoing high risk cardiac surgery. Importantly, this project is being targeted as a QI initiative because there is no evaluation of new technology or procedures. All technologies and procedures are currently being used for patients undergoing cardiac surgery. Rather this project is evaluating the implementation of a multi-dispclinary developed protocol that seeks to remove variability in which providers are currently treating patients hemodynamics during and acutely after cardiac surgery. Previous research has demonstrated that implementation of hemodynamic management protocols improves perioperative outcome in surgical patients. This project seeks to evaluate the impact of implementing this protocol as the new clinical standard for high-risk cardiac surgery patients. Specifically, this protocol would be a comprehensive hemodynamic management strategy that would-be initiated in the operating room post-bypass and then continued for the first 12 hours in the intensive care unit (see figure below). To restate, all technologies and procedures are currently being performed for these patients, however, there has not been a protocol guiding how practionioners use this technology. The project is evaluating the impact of protocolized treatment strategies. Importantly this protocol has been designed, reviewed and agreed by the motivation of the physicians who are currently responsible for managing these patients hemodynamics. Since this project does involve alterations in procedures or technologies we are seeking to proceed as a quality improvement project. Additionally the protocol is one that has been reviewed and agreed to provide the optimal management strategy for these patients. This again is the overall focus of this project, to implement a hemodynamic management pro

Interventions

  • DEVICE Hemodynamic monitoring

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2019-01-17
Est. Completion 2020-06-30

Sponsor

Loma Linda University

237 total trials

What the Registry Record Tells You About NCT04458701

The ClinicalTrials.gov registry entry for NCT04458701 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Hemodynamic monitoring is the first listed.

NCT04458701 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04458701 about?

NCT04458701 is a clinical study titled "Prospective Data Analysis of a Quality Improvement Initiative in High Risk Cardiac Surgery Patients". This project is designed to assess the impact of implementing a hemodynamic optimization protocol, utilizing flow guided parameters that is provided by technology from Edwards Lifesciences, for patients undergoing high risk cardiac surgery. Importantly, this project is being targeted as a QI initiat...

What is the current status of trial NCT04458701?

This trial is currently completed. The enrollment target is 195 participants. The study started on 2019-01-17. Estimated completion is 2020-06-30.

What interventions are being tested in trial NCT04458701?

The interventions under investigation include: Hemodynamic monitoring (DEVICE).

Who is sponsoring clinical trial NCT04458701?

This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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