Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship (EPIC)

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.

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.

Antimicrobial Stewardship, Cardiovascular Surgeries, Computerized Decision Support System, Coronary Artery Disease, Valve Heart Disease

Computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm.

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.

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

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.

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.

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.

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)

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

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.

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.

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.