Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery

Sepsis Clinical Trial

— HAI  

Official title:

Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068716
• Other study ID #: HAI_Umich
• Secondary ID: 2004-0428
• Status: Completed
• Start date: March 2014
• Est. completion date: September 29, 2018

Study information

• Verified date: October 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 911754
• Est. completion date: September 29, 2018
• Est. primary completion date: September 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant women,

• children,

• endocarditis

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Deep Sternal Infection
• Healthcare Associated Infectious Disease
• Infection
• Pneumonia
• Sepsis
• Sternal Superficial Wound Infection
• Wound Infection

Locations

Country	Name	City	State
United States	Mstcvs-Qc	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Donald Likosky	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Determin — View Citation

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 H — View Citation

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 b — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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