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Completed

NCT Number: NCT04328090

Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship

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.

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Key information

Conditions

Antimicrobial Stewardship Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Cardiovascular Surgeries Computerized Decision Support System Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Valve Heart Disease Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computer based Antimicrobial stewardship (AMS) intervention system

Other
  • Re-evaluation alerts and decision support for the duration of antimicrobial treatment.
  • Re-evaluation alerts and decision support for the choice of antimicrobial.
  • Quality control audit and feedback.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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)

  10. 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)

  11. 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

  12. 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:

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

  13. 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)

  14. 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

    • Acute renal dysfunction within 48 hours (ICD 10: N17);
    • 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

  15. 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)

  16. 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

  17. 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

  18. 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.

  19. 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.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship on the Antimicrobial Use After Cardiovascular Surgeries

Acronym: EPIC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2020
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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