Antibiotic Prophylaxis, Biomarkers, CIED Related Infection, CIED-related Infections, Heart Block
Conditions
Keywords
heart block, CIED related infection, antibiotic prophylaxis, biomarkers
Brief summary
Effect of single dose & intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection & biomarkers
Interventions
DRUGPlacebo 3 days
Placebo for 3 days after CIED implantation
DRUGAmpicillin sulbactam 3 days
Ampicillin sulbactam 1.5 gram IV BID for 3 days after CIED implantation
Sponsors
Dr. Kariadi General Hospital Medical Center
Universitas Diponegoro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double blind randomized controlled trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Indication of CIED implantation * No infection at the time of implantation
Exclusion criteria
* Refuse to participate in the study * Allergy to ampicillin sulbactam * CIED debridement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CIED-related infection | Baseline, 3 days, 7 days, and 28 days | Incidence of superficial infection, pocket infection, infective endocarditis, or rehospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Presepsin | Baseline and 24 hours after CIED implantation | Delta level of Presepsin |
| Level of Interleukin-6 | Baseline and 24 hours after CIED implantation | Delta level of Interleukin-6 |
| Level of Procalcitonin | Baseline and 24 hours after CIED implantation | Delta level of Procalcitonin |
Countries
Indonesia
Outcome results
None listed