NCT02068716

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
911,754

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

4.6 years

First QC Date

February 19, 2014

Last Update Submit

October 19, 2018

Conditions

Keywords

Healthcare acquired infectionsCardiovascular SurgeryMediastinitisThoracotomyConduit harvest or cannulation site

Outcome Measures

Primary Outcomes (1)

  • 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.

    In-hospital or within the first 30 days (for surgical infections) after surgery

Study Arms (1)

Adults with HAIs

Adult cardiac surgery patients who develop infections in hospitals within 30 days post surgery. We will exclude patients presenting with endocarditis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing adult cardiac surgery

You may qualify if:

  • Female and male adult patients 18 and over undergoing cardiac surgery within the state of Michigan from January 1, 2011 through June 30, 2013.

You may not qualify if:

  • Pregnant women,
  • children,
  • endocarditis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mstcvs-Qc

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (5)

  • 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.

  • Likosky 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.

  • Strobel 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.

  • Brescia 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.

  • Likosky 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.

MeSH Terms

Conditions

Cross InfectionSepsisPneumoniaMediastinitis

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeInflammationRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesMediastinal DiseasesThoracic Diseases

Study Officials

  • Donald S Likosky, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 21, 2014

Study Start

March 1, 2014

Primary Completion

September 29, 2018

Study Completion

September 29, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Locations