Antimicrobial StewardshipEPICNCT04328090

Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship

A study testing Computer based Antimicrobial stewardship (AMS) intervention system in people with Antimicrobial Stewardship and Cardiovascular Surgeries, run by China National Center for Cardiovascular Diseases at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Antimicrobial Stewardship, Cardiovascular Surgeries, Computerized Decision Support System
What is being tested?: Computer based Antimicrobial stewardship (AMS) intervention system
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,473 participants
Where: 1 siteChina
Study dates: 27 Nov 2020to 30 Jun 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Fuwai Hospital
Beijing, Beijing Municipality, 100037

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions: Antimicrobial Stewardship, Cardiovascular Surgeries, Computerized Decision Support System, Coronary Artery Disease, Valve Heart Disease
Being tested: Computer based Antimicrobial stewardship (AMS) intervention system
Medical subject headings: Coronary Artery Disease, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computer based Antimicrobial stewardship (AMS) intervention systemOther
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.

Study groups in NCT04328090
Study group	Role	What they receive
CDSS-Antimicrobial stewardship	Experimental	Computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm. Receives: Other: Computer based Antimicrobial stewardship (AMS) intervention system
Standard of care	No intervention	Teams in the control arm will continue with usual standard clinical care.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From the date of admission to the date of discharge, assessed up to 3 months.
DOT per 1000 patient-days (PD)
DOT per 1000 patient-days
Measured: From the date of admission to the date of discharge, assessed up to 60 days.

Secondary outcomes (19)

Drug usage (DDDs) per 100 PD
Items issued × Amount of drug per item per 100 PD
Measured: From the date of admission to the date of discharge, assessed up to 60 days.
Drug usage (DDDs) per admission
Items issued × Amount of drug per item per admission
Measured: From the date of admission to the date of discharge, assessed up to 60 days.
Length of therapy (LOT) per 100 PD
Number of days during which antimicrobial is used per 100 PD
Measured: From the date of admission to the date of discharge, assessed up to 60 days.
Length of therapy (LOT) per admission
Number of days during which antimicrobial is used per admission
Measured: From the date of admission to the date of discharge, assessed up to 60 days.
Days per treatment period overall and for specific indications
treatment period: antibiotic treatment not interrupted by more than one calendar day or discharge.
Measured: From the date of admission to the date of discharge, assessed up to 60 days.
Rate of participants with clostridium difficile colitis
Colitis associated with Clostridium difﬁcile infection
Measured: 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.
MRSA=methicillin-resistant Staphylococcus aureus; ESBL-E=extended spectrum beta-lactamase producing Enterobacteriaceae; CRE=Carbapenem resistant Enterobacteriaceae; VRE=vancomycin-resistant enterococci.
Measured: From the date of admission to the date of discharge, assessed up to 60 days.
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.
Measured: 30 days from accomplished of the surgery.
Rate of in-hospital bloodstream infections
Blood stream infection after surgery (ICD 10: A41.9)
Measured: From the date of admission to the date of discharge, assessed up to 60 days.
Rate of in-hospital pneumonia
Pulmonary infection after surgery (ICD 10：J98.402)
Measured: From the date of admission to the date of discharge, assessed up to 60 days.
In-hospital or 30-day mortality, postoperative
mortality with in 30-day after the surgery
Measured: 30 days from accomplished of the surgery or within hospital.
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.
Measured: 30 days from accomplished of the surgery or within hospital.
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)
Measured: 30 days from accomplished of the surgery or within hospital
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
Measured: 30 days from accomplished of the surgery or within hospital
Length of hospital stay (LOS)
Length of hospital stay (LOS)
Measured: 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
Costs of administered antimicrobials (overall and by class) per admission
Measured: From the date of admission to the date of discharge, assessed up to 60 days.
Total costs of hospitalization
Total costs of hospitalization
Measured: From the date of admission to the date of discharge, assessed up to 60 days.
User satisfaction with the system
Using questionnaire and an interview guide for the process evaluation of the intervention system.
Measured: 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
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.
Measured: From the date of inclusion of the first patient to the date of discharge of the last patient, assessed up to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 202030 Jun 2021

First posted31 Mar 2020
Study start27 Nov 2020
Primary completion30 May 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Antimicrobial StewardshipStudies of the same condition, open and under way.
More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: parallel
Masking: None (open label)
Enrolment: 2,473 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04328090
Sponsor's protocol ID: 2020-ZX10
Acronym: EPIC
Status last verified: Mar 2022
First submitted: 17 Mar 2020
Last updated: 9 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yuan X, Chen K, Yuan J, Chu Q, Hu S, Gao Y, Yu F, Diao X, Chen X, Li Y, Sun H, Shu C, Wang W, Pan X, Zhao W, Hu S. Evaluation of the effectiveness and safety of a multi-faceted computerized antimicrobial stewardship intervention in surgical settings: A single-centre cluster-randomized controlled trial. Int J Antimicrob Agents. 2023 May;61(5):106787. doi: 10.1016/j.ijantimicag.2023.106787. Epub 2023 Mar 17.
PubMed 36935089
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship on the Antimicrobial Use After Cardiovascular Surgeries
ClinicalTrials.gov ID: NCT04328090
Acronym / sponsor ID: EPIC / 2020-ZX10
Conditions: Antimicrobial Stewardship, Cardiovascular Surgeries, Computerized Decision Support System, Coronary Artery Disease, Valve Heart Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,473 participants (actual)
Lead sponsor: China National Center for Cardiovascular DiseasesOther government
Study start: 27 Nov 2020 (actual)
Primary completion: 30 May 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 31 Mar 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: parallel

Arm	Type	Receives
CDSS-Antimicrobial stewardship	Experimental	Other: Computer based Antimicrobial stewardship (AMS) intervention systemComputer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm.
Standard of care	No intervention	–Teams in the control arm will continue with usual standard clinical care.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Computer based Antimicrobial stewardship (AMS) intervention system1. 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.	Other	CDSS-Antimicrobial stewardship

Primary outcome

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.
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

19 secondary outcomes

Drug usage (DDDs) per 100 PD
Time frame: 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.
Length of therapy (LOT) per 100 PD
Time frame: 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.
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.
Rate of participants with clostridium difficile colitis
Time frame: 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.
In-hospital or 30-day surgical site infections (SSIs)
Time frame: 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.
Rate of in-hospital pneumonia
Time frame: 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.
In-hospital or 30-day myocardial infarction (MI), postoperative and newly onset
Time frame: 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
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
Length of hospital stay (LOS)
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
Time frame: 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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
Derived from this study: PubMed 36935089Yuan X, Chen K, Yuan J, Chu Q, Hu S, Gao Y, Yu F, Diao X, Chen X, Li Y, Sun H, Shu C, Wang W, Pan X, Zhao W, Hu S. Evaluation of the effectiveness and safety of a multi-faceted computerized antimicrobial stewardship intervention in surgical settings: A single-centre cluster-randomized controlled trial. Int J Antimicrob Agents. 2023 May;61(5):106787. doi: 10.1016/j.ijantimicag.2023.106787. Epub 2023 Mar 17.
Derived from this study: PubMed 33243799Yuan 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shengshou Hu, MD principal investigator

Chinese Academy of Medical Sciences, Fuwai Hospital

Xin Yuan, PhD study chair

Chinese Academy of Medical Sciences, Fuwai Hospital

Kai Chen, PhD study director

Chinese Academy of Medical Sciences, Fuwai Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days of antimicrobial therapy (DOT) per admission (time frame: From the date of admission to the date of discharge, assessed up to 3 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04328090, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.