Coronary Artery Bypass GraftNCT04458701
Prospective Data Analysis of a Quality Improvement Initiative in High Risk Cardiac Surgery Patients
An observational study of Coronary Artery Bypass Graft, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft
- What is being tested?
- Hemodynamic monitoring
- Type of treatment
- Medical device
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2019to 30 Jun 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult high risk cardiac surgical patients undergoing procedures requiring cardiopulmonary bypass. High risk was defined, a priori, as patients who are expected to require an inotropic and/or vasoconstrictive agent for more than 12 hours post-CPB.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
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
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.
- Conditions
- Coronary Artery Bypass Graft
- Being tested
- Hemodynamic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic monitoringDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
ICU length of stay
Measured: days
Secondary outcomes (3)
Major postoperative complications identified as:
- 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.
Measured: during hospitalization
Hospital length of stay
Measured: days
30-day readmission
Measured: days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start17 Jan 2019
- Primary completion1 Feb 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Davinder Ramsingh, MD, Loma Linda University
- Investigators
- Davinder Ramsingh, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458701
- Sponsor's protocol ID
- 5170287
- Status last verified
- Aug 2020
- First submitted
- 1 Jul 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04458701
- Acronym / sponsor ID
- 5170287
- Conditions
- Coronary Artery Bypass Graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult high risk cardiac surgical patients undergoing procedures requiring cardiopulmonary bypass. High risk was defined, a priori, as patients who are expected to require an inotropic and/or vasoconstrictive agent for more than 12 hours post-CPB.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodynamic monitoringThis 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 | Device | – |
Primary outcome
Length of Stay
Time frame: days
ICU length of stay
3 secondary outcomes
Major postoperative complications identified as:
Time frame: during hospitalization
Hospital length of stay
Time frame: days
30-day readmission
Time frame: days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: No
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Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davinder Ramsingh, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass Graft, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (time frame: days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.