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Clinical Trials/NCT04458701
NCT04458701
Completed
Not Applicable

Prospective Data Analysis of a Quality Improvement Initiative for Perioperative Hemodynamic Optimization Therapy and Postoperative Outcomes in Patients Undergoing High-Risk Cardiac Surgery

Loma Linda University1 site in 1 country195 target enrollmentJanuary 17, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Bypass Graft
Sponsor
Loma Linda University
Enrollment
195
Locations
1
Primary Endpoint
Length of Stay
Status
Completed
Last Updated
5 years ago

Overview

Brief 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 protocol to improve outcomes in patients undergoing cardiac surgery.

Registry
clinicaltrials.gov
Start Date
January 17, 2019
End Date
June 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Davinder Ramsingh, MD

MD

Loma Linda University

Eligibility Criteria

Inclusion Criteria

  • (1) the procedure was a first-start case, (2) the procedure was scheduled, (3) the procedure is considered non-emergent, and (4) the cardiac surgery required cardiopulmonary bypass

Exclusion Criteria

  • (1) Patients less than 18 years of age, (2) failure to undergo CPB, (3) non-first-start or emergent classification, (4) as well those who did not receive at least 12 hours of inotropic and/or vasoconstrictive agents were excluded from the study.

Outcomes

Primary Outcomes

Length of Stay

Time Frame: days

ICU length of stay

Secondary Outcomes

  • Hospital length of stay(days)
  • 30-day readmission(days)
  • Major postoperative complications identified as:(during hospitalization)

Study Sites (1)

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