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| Name | Class |
|---|---|
| Dr. Kariadi General Hospital Medical Center | OTHER |
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Effect of single dose & intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection & biomarkers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Placebo Comparator | Ampicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + placebo for 3 days after implantation |
|
| Control | Experimental | Ampicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + ampicillin sulbactam 1.5 gram IV BID for 3 days after implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ampicillin sulbactam 3 days | Drug | Ampicillin sulbactam 1.5 gram IV BID for 3 days after CIED implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CIED-related infection | Incidence of superficial infection, pocket infection, infective endocarditis, or rehospitalization | Baseline, 3 days, 7 days, and 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Presepsin | Delta level of Presepsin | Baseline and 24 hours after CIED implantation |
| Level of Interleukin-6 | Delta level of Interleukin-6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kariadi Central General Hospital | Semarang | Central Java | 50244 | Indonesia |
Waiting for agreement
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Double blind randomized controlled trial
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| Placebo 3 days | Drug | Placebo for 3 days after CIED implantation |
|
| Baseline and 24 hours after CIED implantation |
| Level of Procalcitonin | Delta level of Procalcitonin | Baseline and 24 hours after CIED implantation |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C035444 | sultamicillin |
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