Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship

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• Coronary Artery Disease 5,598
• Heart Diseases 3,639
• Heart Valve Diseases 535

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 2,473 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.

Study arms

• 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

• No intervention
  Standard of care

  Teams in the control arm will continue with usual standard clinical care.

Interventions

• OtherComputer 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.

Primary outcomes

1. Days of antimicrobial therapy (DOT) per admission

   DOT represents a specific antibiotic administered to an individual patient on a calendar day independent of dose and route.

   Time frame: From the date of admission to the date of discharge, assessed up to 3 months.

2. DOT per 1000 patient-days (PD)

   DOT per 1000 patient-days

   Time frame: From the date of admission to the date of discharge, assessed up to 60 days.

Secondary outcomes

1. Drug usage (DDDs) per 100 PD

   Items issued × Amount of drug per item per 100 PD

   Time frame: From the date of admission to the date of discharge, assessed up to 60 days.

2. Drug usage (DDDs) per admission

   Items issued × Amount of drug per item per admission

   Time frame: From the date of admission to the date of discharge, assessed up to 60 days.

3. Length of therapy (LOT) per 100 PD

   Number of days during which antimicrobial is used per 100 PD

   Time frame: From the date of admission to the date of discharge, assessed up to 60 days.

4. Length of therapy (LOT) per admission

   Number of days during which antimicrobial is used per admission

   Time frame: From the date of admission to the date of discharge, assessed up to 60 days.

5. Days per treatment period overall and for specific indications

   treatment period: antibiotic treatment not interrupted by more than one calendar day or discharge.

   Time frame: From the date of admission to the date of discharge, assessed up to 60 days.

6. Rate of participants with clostridium difficile colitis

   Colitis associated with Clostridium difficile infection

   Time frame: From the date of admission to the date of discharge, assessed up to 60 days.

7. Incident clinical cultures with multidrug resistant organisms (MRSA, ESBL-E, CRE, VRE, or Pseudomonas aeruginosa) per 1000 PD and admission.

   MRSA=methicillin-resistant Staphylococcus aureus; ESBL-E=extended spectrum beta-lactamase producing Enterobacteriaceae; CRE=Carbapenem resistant Enterobacteriaceae; VRE=vancomycin-resistant enterococci.

   Time frame: From the date of admission to the date of discharge, assessed up to 60 days.

8. In-hospital or 30-day surgical site infections (SSIs)

   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.

   Time frame: 30 days from accomplished of the surgery.

9. Rate of in-hospital bloodstream infections

   Blood stream infection after surgery (ICD 10: A41.9)

   Time frame: From the date of admission to the date of discharge, assessed up to 60 days.

10. Rate of in-hospital pneumonia

    Pulmonary infection after surgery (ICD 10：J98.402)

    Time frame: From the date of admission to the date of discharge, assessed up to 60 days.

11. In-hospital or 30-day mortality, postoperative

    mortality with in 30-day after the surgery

    Time frame: 30 days from accomplished of the surgery or within hospital.

12. In-hospital or 30-day myocardial infarction (MI), postoperative and newly onset

    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.

    Time frame: 30 days from accomplished of the surgery or within hospital.

13. In-hospital or 30-day stroke, postoperative and newly onset

    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)

    Time frame: 30 days from accomplished of the surgery or within hospital

14. In-hospital or 30-day acute kidney injury (AKI) , postoperative and newly onset

    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

    Time frame: 30 days from accomplished of the surgery or within hospital

15. Length of hospital stay (LOS)

    Length of hospital stay (LOS)

    Time frame: From the date of admission to the date of discharge, assessed up to 60 days.

16. Costs of administered antimicrobials (overall and by class) per admission

    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.

17. Total costs of hospitalization

    Total costs of hospitalization

    Time frame: From the date of admission to the date of discharge, assessed up to 60 days.

18. User satisfaction with the system

    Using questionnaire and an interview guide for the process evaluation of the intervention 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.

19. User compliance with the system

    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.

    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.

Publications

• Yuan X, Chen K, Zhao W, Hu S, Yu F, Diao X, Chen X, Hu S. Open-label, single-centre, cluster-randomised controlled trial to Evaluate the Potential Impact of Computerisedantimicrobial stewardship (EPIC) on the antimicrobial use after cardiovascular surgeries: EPIC trial study original protocol. BMJ Open. 2020 Nov 26;10(11):e039717. doi: 10.1136/bmjopen-2020-039717. PubMed 33243799 ↗

Individual participant data

Plan to share: No