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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04458701
Other study ID # 5170287
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 17, 2019
Est. completion date June 30, 2020

Study information

Verified date August 2020
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 195
Est. completion date June 30, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hemodynamic monitoring
This is 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

Locations

Country Name City State
United States Loma Linda University Medical Center Loma Linda California

Sponsors (2)

Lead Sponsor Collaborator
Loma Linda University Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of Stay ICU length of stay days
Secondary Major postoperative complications identified as: 1) incidence of stroke, (2) incidence of renal failure (defined as a threefold or greater rise in creatinine or new dialysis requirement), (3) prolonged intubation (>24 hours), and/or (4) a sternal wound infection. during hospitalization
Secondary Hospital length of stay days
Secondary 30-day readmission days
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