Healthcare Associated Infectious DiseaseHAINCT02068716
Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery
An observational study of Healthcare Associated Infectious Disease and Sternal Superficial Wound Infection, run by Dr. Donald Likosky at 1 site in United States.
Trial summary
Our Aim is to identify patient risk factors and clinical practices associated with healthcare-acquired infections (HAIs) after cardiac surgery. We will use prospectively collected data housed within the MSTCVS-QC (Michigan Society of Thoracic \& Cardiovascular Surgeons Quality Collaborative) to reveal risk factors… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthcare Associated Infectious Disease, Sternal Superficial Wound Infection, Sepsis
- How many people
- 911,754 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 29 Sep 2018
- 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: Patients undergoing adult cardiac surgery
Who may be able to join
- Female and male adult patients 18 and over undergoing cardiac surgery within the state of Michigan from January 1, 2011 through June 30, 2013.
Who cannot join
- Pregnant women,
- children,
- endocarditis
Trial locations and contacts
1 site in 1 country.
About this study
Our Aim is to identify patient risk factors and clinical practices associated with healthcare-acquired infections (HAIs) after cardiac surgery.
We will use prospectively collected data housed within the MSTCVS-QC (Michigan Society of Thoracic \& Cardiovascular Surgeons Quality Collaborative) to reveal risk factors that elevate a patient's risk of developing HAIs. The results of this analysis will form the foundation for the development of standardized regional practices to reduce HAIs. We will explore the effect of traditional patient-level measures (age, sex, comorbid conditions), process measures (timing and selection of antibiotics, continuous insulin infusion, transfusions), and surgical practices (use of bilateral internal mammary artery usage among diabetics, vein harvesting approach).
Read the detailed description
More than 400,000 coronary artery bypass grafting (CABG) procedures are performed every year in the United States (U.S.). Patients undergoing CABG surgery are at risk for a number of adverse sequelae, many of which impact survival and contribute to overall health-care costs. Healthcare-acquired infections (HAIs), including pneumonia and superficial and deep sternal wound infections, occur among 16% of CABG patients and elevate a patient's risk of mortality and add excess upfront and long-term expenditures to the health care system.
A number of barriers prevent wide-scale improvements in HAl rates within the setting of CABG surgery. While a number of HAl prophylaxis measures have been developed, these measures do not fully encompass the set of practices that may impact a patient's risk of HAl. Identifying cardiac surgery specific risk factors would serve as the foundation for targeted quality improvement strategies. In the absence of definitive data concerning best practices, HAl prophylaxis is variable across surgeons and institutions, resulting in unnecessary morbidity and cost. Prior work has shown the value of implementing evidence-based protocols in the general intensive care unit setting. To what extent the implementation of cardiac surgery specific standardized practices results in lower HAl rates is uncertain. An understanding of the effectiveness of this approach would certainly assist surgeons and institutions in providing safer care to their patient populations.
Rates of HAIs vary from 0-26% across the 33 institutions performing CABG surgery in Michigan. This application seeks to reduce this rate by identifying and subsequently implementing standardized practices, and evaluating their impact on HAl rates. This study will be based on the prospective data and regional quality improvement activities and infrastructure of the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative (MSTCVS-QC). We will evaluate the effectiveness of these standardized practices in reducing HAIs regionally and relative to national rates during the same time period.
Our Aim is to identify patient risk factors and clinical practices associated with HAIs after cardiac surgery.
We will use prospectively collected data housed within the MSTCVS-QC to reveal risk factors that elevate a patient's risk of developing HAIs. The results of this analysis will form the foundation for the development of standardized regional practices to reduce HAIs. We will explore the effect of traditional patient-level measures (age, sex, comorbid conditions), process measures (timing and selection of antibiotics, continuous insulin infusion, transfusions), and surgical practices (use of bilateral internal mammary artery usage among diabetics, vein harvesting approach).
- Conditions
- Healthcare Associated Infectious Disease, Sternal Superficial Wound Infection, Sepsis, Pneumonia, Deep Sternal Infection
- Keywords
- Healthcare acquired infections, Cardiovascular Surgery, Mediastinitis, Thoracotomy, Conduit harvest or cannulation site
- Medical subject headings
- Cross Infection, Sepsis, Pneumonia, Mediastinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with HAIs | Adult cardiac surgery patients who develop infections in hospitals within 30 days post surgery. We will exclude patients presenting with endocarditis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients having a healthcare-acquired infection (HAIs) post cardiac surgery.
Overall HAIs include pneumonia, sepsis/septicemia, and surgical site infections, including deep sternal wound, thoracotomy, and harvest/cannulation site infections.
Measured: In-hospital or within the first 30 days (for surgical infections) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startMar 2014
- Primary completion29 Sep 2018
- Study completion29 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthcare Associated Infectious DiseaseStudies of the same condition, open and under way.
- 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
- 911,754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Donald Likosky
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor-investigator, Dr. Donald Likosky, University of Michigan
- Investigators
- Donald S Likosky, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068716
- Sponsor's protocol ID
- HAI_Umich
- Other IDs
- 2004-0428
- Acronym
- HAI
- Status last verified
- Oct 2018
- First submitted
- 19 Feb 2014
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Shih T, Zhang M, Kommareddi M, Boeve TJ, Harrington SD, Holmes RJ, Roth G, Theurer PF, Prager RL, Likosky DS; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Center-level variation in infection rates after coronary artery bypass grafting. Circ Cardiovasc Qual Outcomes. 2014 Jul;7(4):567-73. doi: 10.1161/CIRCOUTCOMES.113.000770. Epub 2014 Jul 1.
PubMed 24987052Likosky DS, Wallace AS, Prager RL, Jacobs JP, Zhang M, Harrington SD, Saha-Chaudhuri P, Theurer PF, Fishstrom A, Dokholyan RS, Shahian DM, Rankin JS; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Sources of Variation in Hospital-Level Infection Rates After Coronary Artery Bypass Grafting: An Analysis of The Society of Thoracic Surgeons Adult Heart Surgery Database. Ann Thorac Surg. 2015 Nov;100(5):1570-5; discussion 1575-6. doi: 10.1016/j.athoracsur.2015.05.015. Epub 2015 Aug 28.
PubMed 26321440Strobel RJ, Liang Q, Zhang M, Wu X, Rogers MA, Theurer PF, Fishstrom AB, Harrington SD, DeLucia A 3rd, Paone G, Patel HJ, Prager RL, Likosky DS; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. A Preoperative Risk Model for Postoperative Pneumonia After Coronary Artery Bypass Grafting. Ann Thorac Surg. 2016 Oct;102(4):1213-9. doi: 10.1016/j.athoracsur.2016.03.074. Epub 2016 Jun 1.
PubMed 27261082Brescia AA, Rankin JS, Cyr DD, Jacobs JP, Prager RL, Zhang M, Matsouaka RA, Harrington SD, Dokholyan RS, Bolling SF, Fishstrom A, Pasquali SK, Shahian DM, Likosky DS; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Determinants of Variation in Pneumonia Rates After Coronary Artery Bypass Grafting. Ann Thorac Surg. 2018 Feb;105(2):513-520. doi: 10.1016/j.athoracsur.2017.08.012. Epub 2017 Nov 23.
PubMed 29174785Likosky DS, Harrington SD, Cabrera L, DeLucia A 3rd, Chenoweth CE, Krein SL, Thibault D, Zhang M, Matsouaka RA, Strobel RJ, Prager RL. Collaborative Quality Improvement Reduces Postoperative Pneumonia After Isolated Coronary Artery Bypass Grafting Surgery. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004756. doi: 10.1161/CIRCOUTCOMES.118.004756.
PubMed 30571334
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02068716
- Acronym / sponsor ID
- HAI / HAI_Umich
- Conditions
- Healthcare Associated Infectious Disease, Sternal Superficial Wound Infection, Sepsis, Pneumonia, Deep Sternal Infection
- Keywords
- Healthcare acquired infections, Cardiovascular Surgery, Mediastinitis, Thoracotomy, Conduit harvest or cannulation site
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 911,754 participants (actual)
- Lead sponsor
- Dr. Donald LikoskyUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Mar 2014
- Primary completion
- 29 Sep 2018 (actual)
- Study completion
- 29 Sep 2018 (actual)
- First posted
- 21 Feb 2014 (estimated)
- 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.
Our Aim is to identify patient risk factors and clinical practices associated with healthcare-acquired infections (HAIs) after cardiac surgery.
We will use prospectively collected data housed within the MSTCVS-QC (Michigan Society of Thoracic \& Cardiovascular Surgeons Quality Collaborative) to reveal risk factors that elevate a patient's risk of developing HAIs. The results of this analysis will form the foundation for the development of standardized regional practices to reduce HAIs. We will explore the effect of traditional patient-level measures (age, sex, comorbid conditions), process measures (timing and selection of antibiotics, continuous insulin infusion, transfusions), and surgical practices (use of bilateral internal mammary artery usage among diabetics, vein harvesting approach).
Detailed description
More than 400,000 coronary artery bypass grafting (CABG) procedures are performed every year in the United States (U.S.). Patients undergoing CABG surgery are at risk for a number of adverse sequelae, many of which impact survival and contribute to overall health-care costs. Healthcare-acquired infections (HAIs), including pneumonia and superficial and deep sternal wound infections, occur among 16% of CABG patients and elevate a patient's risk of mortality and add excess upfront and long-term expenditures to the health care system.
A number of barriers prevent wide-scale improvements in HAl rates within the setting of CABG surgery. While a number of HAl prophylaxis measures have been developed, these measures do not fully encompass the set of practices that may impact a patient's risk of HAl. Identifying cardiac surgery specific risk factors would serve as the foundation for targeted quality improvement strategies. In the absence of definitive data concerning best practices, HAl prophylaxis is variable across surgeons and institutions, resulting in unnecessary morbidity and cost. Prior work has shown the value of implementing evidence-based protocols in the general intensive care unit setting. To what extent the implementation of cardiac surgery specific standardized practices results in lower HAl rates is uncertain. An understanding of the effectiveness of this approach would certainly assist surgeons and institutions in providing safer care to their patient populations.
Rates of HAIs vary from 0-26% across the 33 institutions performing CABG surgery in Michigan. This application seeks to reduce this rate by identifying and subsequently implementing standardized practices, and evaluating their impact on HAl rates. This study will be based on the prospective data and regional quality improvement activities and infrastructure of the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative (MSTCVS-QC). We will evaluate the effectiveness of these standardized practices in reducing HAIs regionally and relative to national rates during the same time period.
Our Aim is to identify patient risk factors and clinical practices associated with HAIs after cardiac surgery.
We will use prospectively collected data housed within the MSTCVS-QC to reveal risk factors that elevate a patient's risk of developing HAIs. The results of this analysis will form the foundation for the development of standardized regional practices to reduce HAIs. We will explore the effect of traditional patient-level measures (age, sex, comorbid conditions), process measures (timing and selection of antibiotics, continuous insulin infusion, transfusions), and surgical practices (use of bilateral internal mammary artery usage among diabetics, vein harvesting approach).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with HAIs | – | –Adult cardiac surgery patients who develop infections in hospitals within 30 days post surgery. We will exclude patients presenting with endocarditis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing adult cardiac surgery
Key inclusion criteria (1 listed)
- Female and male adult patients 18 and over undergoing cardiac surgery within the state of Michigan from January 1, 2011 through June 30, 2013.
Key exclusion criteria (3 listed)
- Pregnant women,
- children,
- endocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent of patients having a healthcare-acquired infection (HAIs) post cardiac surgery.
Time frame: In-hospital or within the first 30 days (for surgical infections) after surgery
Overall HAIs include pneumonia, sepsis/septicemia, and surgical site infections, including deep sternal wound, thoracotomy, and harvest/cannulation site infections.
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 23 Oct 2018.
- Results publication: PubMed 24987052Shih T, Zhang M, Kommareddi M, Boeve TJ, Harrington SD, Holmes RJ, Roth G, Theurer PF, Prager RL, Likosky DS; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Center-level variation in infection rates after coronary artery bypass grafting. Circ Cardiovasc Qual Outcomes. 2014 Jul;7(4):567-73. doi: 10.1161/CIRCOUTCOMES.113.000770. Epub 2014 Jul 1.
- Results publication: PubMed 26321440Likosky DS, Wallace AS, Prager RL, Jacobs JP, Zhang M, Harrington SD, Saha-Chaudhuri P, Theurer PF, Fishstrom A, Dokholyan RS, Shahian DM, Rankin JS; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Sources of Variation in Hospital-Level Infection Rates After Coronary Artery Bypass Grafting: An Analysis of The Society of Thoracic Surgeons Adult Heart Surgery Database. Ann Thorac Surg. 2015 Nov;100(5):1570-5; discussion 1575-6. doi: 10.1016/j.athoracsur.2015.05.015. Epub 2015 Aug 28.
- Results publication: PubMed 27261082Strobel RJ, Liang Q, Zhang M, Wu X, Rogers MA, Theurer PF, Fishstrom AB, Harrington SD, DeLucia A 3rd, Paone G, Patel HJ, Prager RL, Likosky DS; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. A Preoperative Risk Model for Postoperative Pneumonia After Coronary Artery Bypass Grafting. Ann Thorac Surg. 2016 Oct;102(4):1213-9. doi: 10.1016/j.athoracsur.2016.03.074. Epub 2016 Jun 1.
- Results publication: PubMed 29174785Brescia AA, Rankin JS, Cyr DD, Jacobs JP, Prager RL, Zhang M, Matsouaka RA, Harrington SD, Dokholyan RS, Bolling SF, Fishstrom A, Pasquali SK, Shahian DM, Likosky DS; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Determinants of Variation in Pneumonia Rates After Coronary Artery Bypass Grafting. Ann Thorac Surg. 2018 Feb;105(2):513-520. doi: 10.1016/j.athoracsur.2017.08.012. Epub 2017 Nov 23.
- Derived from this study: PubMed 30571334Likosky DS, Harrington SD, Cabrera L, DeLucia A 3rd, Chenoweth CE, Krein SL, Thibault D, Zhang M, Matsouaka RA, Strobel RJ, Prager RL. Collaborative Quality Improvement Reduces Postoperative Pneumonia After Isolated Coronary Artery Bypass Grafting Surgery. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004756. doi: 10.1161/CIRCOUTCOMES.118.004756.
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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.
Donald S Likosky, Ph.D. principal investigator
University of Michigan
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 Healthcare Associated Infectious Disease and Sternal Superficial Wound Infection, run by Dr. Donald Likosky 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 3 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 23 Oct 2018. 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?
Percent of patients having a healthcare-acquired infection (HAIs) post cardiac surgery. (time frame: In-hospital or within the first 30 days (for surgical infections) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02068716, which also lists 5 linked publications.
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 23 Oct 2018.