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

Sponsor
Loma Linda University (Other)
Overall Status
Completed
CT.gov ID
NCT04458701
Collaborator
Edwards Lifesciences (Industry)
195
1
17.4
11.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hemodynamic monitoring

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
195 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prospective Data Analysis of a Quality Improvement Initiative for Perioperative Hemodynamic Optimization Therapy and Postoperative Outcomes in Patients Undergoing High-Risk Cardiac Surgery
Actual Study Start Date :
Jan 17, 2019
Actual Primary Completion Date :
Feb 1, 2020
Actual Study Completion Date :
Jun 30, 2020

Outcome Measures

Primary Outcome Measures

  1. Length of Stay [days]

    ICU length of stay

Secondary Outcome Measures

  1. Major postoperative complications identified as: [during hospitalization]

    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.

  2. Hospital length of stay [days]

  3. 30-day readmission [days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loma Linda University Medical Center Loma Linda California United States 92354

Sponsors and Collaborators

  • Loma Linda University
  • Edwards Lifesciences

Investigators

  • Principal Investigator: Davinder Ramsingh, MD, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Davinder Ramsingh, MD, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT04458701
Other Study ID Numbers:
  • 5170287
First Posted:
Jul 7, 2020
Last Update Posted:
Aug 31, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Aug 31, 2020