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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2473

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Over 18 years of age;
  2. Receiving at least one open-chest cardiovascular surgery during the same admission.

Exclusion Criteria:

  1. Intravenous or oral antimicrobial use within two weeks before surgery;
  2. Emergent/urgent surgery;
  3. Admitted for isolated stenting or heart transplantation or implantation of ventricular assist device or implantation of extracorporeal membrane oxygenation;
  4. Admitted for subacute bacterial endocarditis;
  5. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CDSS-Antimicrobial stewardship
Computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm.
Other: Computer based Antimicrobial stewardship (AMS) intervention system
  1. Re-evaluation alerts and decision support for the duration of antimicrobial treatment.
  2. Re-evaluation alerts and decision support for the choice of antimicrobial.
  3. Quality control audit and feedback.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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:

  1. Elevation of cardiac troponin (cTn)>10 times of the 9th percentile upper reference limit with patients with normal baseline;
  2. For patients with elevated preprocedural cTn values, elevation of cTn>10 fold increase and manifest a change from the baseline value of over 20%;
  3. With as least one of the following:
  4. Development of new pathological Q waves;
  5. Imaging evidence of loss of viable myocardium that is presumed to be new and in a pattern consistent with an ischemic aetiology;
  6. Angiographic findings consistent with a procedural flow-limiting complication.
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

  1. Acute renal dysfunction within 48 hours (ICD 10: N17);
  2. AKI stage I: creatinine≥26.5µmol/L; creatinine over 1.5-1.9 times of baseline value; urine output<0.5ml/kg/hour for 6-12
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.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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