- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04328090
Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship (EPIC)
March 7, 2022 updated by: Shengshou Hu, China National Center for Cardiovascular Diseases
Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship on the Antimicrobial Use After Cardiovascular Surgeries
This trial is an open-label, two-arm, cluster-randomized, controlled trial with cardiovascular surgical teams as the unit of randomization.
Eligible teams with written consent are randomized to the intervention or control arm by random number generator.
Computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm.
Teams in the control arm will continue with usual clinical care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of the EPIC trial is to assess if a multicomponent computer-based system incorporated into the workflow can reduce days of therapy (DOT) per admission after cardiovascular surgeries in the intervention surgical teams compared with controlled surgical teams, over a one-year period.
This trial is an open-label, two-arm, cluster-randomized, controlled trial with cardiovascular surgical teams as the unit of randomization.
Eligible teams with written consent are randomized to the intervention or control arm by random number generator.
Computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm.
Teams in the control arm will continue with usual clinical care.
The intervention includes re-evaluation alerts and decision support for the duration of antimicrobial treatment, re-evaluation alerts and decision support for the choice of antimicrobial, and quality control audit and feedback.
Nine teams per arm with an average size of 1125 admissions will be recruited.
Primary outcome will be the overall systemic antibiotic use measured in DOT of systemic antibiotic use per admission.
Secondary outcomes include a series of indices to evaluate antimicrobial use, microbial resistance, perioperative infection outcomes, patient safety, resource consumption and user compliance/satisfaction.
Study Type
Interventional
Enrollment (Actual)
2473
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100037
- Fuwai Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Over 18 years of age;
- Receiving at least one open-chest cardiovascular surgery during the same admission.
Exclusion Criteria:
- Intravenous or oral antimicrobial use within two weeks before surgery;
- Emergent/urgent surgery;
- Admitted for isolated stenting or heart transplantation or implantation of ventricular assist device or implantation of extracorporeal membrane oxygenation;
- Admitted for subacute bacterial endocarditis;
- Length of ICU stay over 48 hours.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CDSS-Antimicrobial stewardship
Computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm.
|
|
No Intervention: Standard of care
Teams in the control arm will continue with usual standard clinical care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days of antimicrobial therapy (DOT) per admission
Time Frame: From the date of admission to the date of discharge, assessed up to 3 months.
|
DOT represents a specific antibiotic administered to an individual patient on a calendar day independent of dose and route.
|
From the date of admission to the date of discharge, assessed up to 3 months.
|
DOT per 1000 patient-days (PD)
Time Frame: From the date of admission to the date of discharge, assessed up to 60 days.
|
DOT per 1000 patient-days
|
From the date of admission to the date of discharge, assessed up to 60 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drug usage (DDDs) per 100 PD
Time Frame: From the date of admission to the date of discharge, assessed up to 60 days.
|
Items issued × Amount of drug per item per 100 PD
|
From the date of admission to the date of discharge, assessed up to 60 days.
|
Drug usage (DDDs) per admission
Time Frame: From the date of admission to the date of discharge, assessed up to 60 days.
|
Items issued × Amount of drug per item per admission
|
From the date of admission to the date of discharge, assessed up to 60 days.
|
Length of therapy (LOT) per 100 PD
Time Frame: From the date of admission to the date of discharge, assessed up to 60 days.
|
Number of days during which antimicrobial is used per 100 PD
|
From the date of admission to the date of discharge, assessed up to 60 days.
|
Length of therapy (LOT) per admission
Time Frame: From the date of admission to the date of discharge, assessed up to 60 days.
|
Number of days during which antimicrobial is used per admission
|
From the date of admission to the date of discharge, assessed up to 60 days.
|
Days per treatment period overall and for specific indications
Time Frame: From the date of admission to the date of discharge, assessed up to 60 days.
|
treatment period: antibiotic treatment not interrupted by more than one calendar day or discharge.
|
From the date of admission to the date of discharge, assessed up to 60 days.
|
Rate of participants with clostridium difficile colitis
Time Frame: From the date of admission to the date of discharge, assessed up to 60 days.
|
Colitis associated with Clostridium difficile infection
|
From the date of admission to the date of discharge, assessed up to 60 days.
|
Incident clinical cultures with multidrug resistant organisms (MRSA, ESBL-E, CRE, VRE, or Pseudomonas aeruginosa) per 1000 PD and admission.
Time Frame: From the date of admission to the date of discharge, assessed up to 60 days.
|
MRSA=methicillin-resistant Staphylococcus aureus; ESBL-E=extended spectrum beta-lactamase producing Enterobacteriaceae; CRE=Carbapenem resistant Enterobacteriaceae; VRE=vancomycin-resistant enterococci.
|
From the date of admission to the date of discharge, assessed up to 60 days.
|
In-hospital or 30-day surgical site infections (SSIs)
Time Frame: 30 days from accomplished of the surgery.
|
Occurs within 30 days postoperatively and involves skin or subcutaneous tissue of the incision and at least one of the following: (1) purulent drainage from the incision, (2) organisms isolated from an aseptically obtained culture of fluid or tissue from the incision, (3) at least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat, and incision is deliberately opened by surgeon and is culture-positive or not cultured (a culture-negative finding does not meet this criterion), and (4) diagnosis of SSI by the surgeon or attending physician.
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30 days from accomplished of the surgery.
|
Rate of in-hospital bloodstream infections
Time Frame: From the date of admission to the date of discharge, assessed up to 60 days.
|
Blood stream infection after surgery (ICD 10: A41.9)
|
From the date of admission to the date of discharge, assessed up to 60 days.
|
Rate of in-hospital pneumonia
Time Frame: From the date of admission to the date of discharge, assessed up to 60 days.
|
Pulmonary infection after surgery (ICD 10:J98.402)
|
From the date of admission to the date of discharge, assessed up to 60 days.
|
In-hospital or 30-day mortality, postoperative
Time Frame: 30 days from accomplished of the surgery or within hospital.
|
mortality with in 30-day after the surgery
|
30 days from accomplished of the surgery or within hospital.
|
In-hospital or 30-day myocardial infarction (MI), postoperative and newly onset
Time Frame: 30 days from accomplished of the surgery or within hospital.
|
MI (in accordance with the fourth edition of MI definition) was termed type 5 MI, procedure related MI. Briefly, the criteria are as follows:
|
30 days from accomplished of the surgery or within hospital.
|
In-hospital or 30-day stroke, postoperative and newly onset
Time Frame: 30 days from accomplished of the surgery or within hospital
|
Stroke refers to newly onset stroke after surgery (ICD 10: I60.0-I60.9;
I61.0-I61.9;
I62.0; I62.1; I62.9; I63.0-I63.9;
I64)
|
30 days from accomplished of the surgery or within hospital
|
In-hospital or 30-day acute kidney injury (AKI) , postoperative and newly onset
Time Frame: 30 days from accomplished of the surgery or within hospital
|
AKI refers to newly onset AKI after surgery
|
30 days from accomplished of the surgery or within hospital
|
Length of hospital stay (LOS)
Time Frame: From the date of admission to the date of discharge, assessed up to 60 days.
|
Length of hospital stay (LOS)
|
From the date of admission to the date of discharge, assessed up to 60 days.
|
Costs of administered antimicrobials (overall and by class) per admission
Time Frame: From the date of admission to the date of discharge, assessed up to 60 days.
|
Costs of administered antimicrobials (overall and by class) per admission
|
From the date of admission to the date of discharge, assessed up to 60 days.
|
Total costs of hospitalization
Time Frame: From the date of admission to the date of discharge, assessed up to 60 days.
|
Total costs of hospitalization
|
From the date of admission to the date of discharge, assessed up to 60 days.
|
User satisfaction with the system
Time Frame: From the date of inclusion of the first patient to the date of discharge of the last patient, assessed up to 12 months.
|
Using questionnaire and an interview guide for the process evaluation of the intervention system.
|
From the date of inclusion of the first patient to the date of discharge of the last patient, assessed up to 12 months.
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User compliance with the system
Time Frame: From the date of inclusion of the first patient to the date of discharge of the last patient, assessed up to 12 months.
|
Ccompliance with the multicomponent intervention protocols will be assessed.
This will be done by evaluating the total number of times the intervention tools fail to change the physicians' decision on antimicrobial prescription over the intervention period.
|
From the date of inclusion of the first patient to the date of discharge of the last patient, assessed up to 12 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shengshou Hu, MD, Fuwai Hospital
- Study Chair: Xin Yuan, PhD, Fuwai Hospital
- Study Director: Kai Chen, PhD, Fuwai Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2020
Primary Completion (Actual)
May 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
March 17, 2020
First Submitted That Met QC Criteria
March 29, 2020
First Posted (Actual)
March 31, 2020
Study Record Updates
Last Update Posted (Actual)
March 9, 2022
Last Update Submitted That Met QC Criteria
March 7, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-ZX10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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