Biomarkers Clinical Trial
— BI-PACEDOfficial title:
Effect of Single Dose & Intrapocket Prophylactic Antibiotic to Cardiac Implantable Electronic Device-related Infection & Biomarkers
Effect of single dose & intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection & biomarkers
| Status | Recruiting |
| Enrollment | 90 |
| Est. completion date | January 2025 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Indonesia | Kariadi Central General Hospital | Semarang | Central Java |
| Lead Sponsor | Collaborator |
|---|---|
| Universitas Diponegoro | Dr. Kariadi General Hospital Medical Center |
Indonesia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CIED-related infection | Event of superficial infection, pocket infection, infective endocarditis, or rehospitalization | Baseline, 3 days, 7 days, and 28 days | |
| Secondary | Presepsin | Delta level of Presepsin | Baseline and 24 hours after CIED implantation | |
| Secondary | Interleukin-6 | Delta level of Interleukin-6 | Baseline and 24 hours after CIED implantation | |
| Secondary | Procalcitonin | Delta level of Procalcitonin | Baseline and 24 hours after CIED implantation |
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