Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04736979 |
| Other study ID # |
170499 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2017 |
| Est. completion date |
August 31, 2020 |
Study information
| Verified date |
April 2022 |
| Source |
University Hospital of Ferrara |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study was aimed at the evaluation of a new protocol of antibiotic prophylaxis,
stratified according to individual infective risk calculated with the Shariff score at the
moment of cardiac implantable electronic device (CIED) implantation.
Description:
Prospective, single centre, cohort study. Patients undergoing CIED surgery in a 3-years
period were considered for participation. In particular, patients were eligible if undergoing
first implantation or replacement or upgrade of pacemaker or implantable
cardioverter-defibrillator (ICD), including cardiac resynchronization therapy (CRT).
At the time of enrolment, before index procedure, the Shariff score was calculated for every
patient. According to the score, patients were stratified in two groups: low infective risk
(score <3) and high infective risk (score ≥3). Two different protocols of antibiotic
prophylaxis were administered according to risk stratification. Patients in the "low risk"
group were treated with only two doses of antibiotics, both intravenous, of whom the first
one hour before skin incision and the second after eight hours. Patients in the "high risk"
group were treated with intravenous prophylaxis for two full days (of whom the first
administration one hour before skin incision and the others every eight hours), followed by
other seven days of oral prophylaxis, for a total of nine days. Thereby, every patient
received one administration of intravenous antibiotic one hour before skin incision and a
second administration after eight hours, while patients in the low risk group did not receive
other antibiotics and patients in the high risk group continued intravenous antibiotics every
eight hours for two days, followed by oral antibiotics for other seven days.
The intended drug for antibiotic prophylaxis was amoxicillin + clavulanic acid unless the
patient had a history of allergic reactions to penicillin. The dosage was dependent on renal
function: for intravenous amoxicillin + clavulanic acid 2.2 g in patients with creatinine
clearance (CrCl) <30 ml/min and 1.2 g in patients with CrCl >30ml/min, for oral amoxicillin +
clavulanic acid 1 g every 8 hours in patients with <30 ml/min and 1 g every 12 hours in
patients with CrCl >30ml/min. In case of penicillin allergy, clindamycin was chosen. The
intravenous dosage was 600 mg every 8 hours for CrCl <30 ml/min and 600 mg every 12 hours for
CrCl >30 ml/min, while the oral dosage was 450 mg every 8 hours for CrCl <30 ml/min and 450
mg every 12 hours for CrCl >30 ml/min.
Patients who were already in antibiotic therapy at the time of index procedure (for reasons
other than CIED implantation) were not stratified in one of the two groups: post-operative
antibiotics were continued according to clinical indications and not to the study protocol.
This group included patients with a documented or suspected infection before surgery in whom
the CIED procedure was judged not deferrable.
