Biomarkers & Infection After Prophylactic Antibiotic in Cardiac Implantable Electronic Device Implantation

Universitas Diponegoro60 enrolled

Overview

Effect of single dose \& intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection \& biomarkers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Heart Block CIED Related Infection CIED-related Infections Antibiotic Prophylaxis Biomarkers

Interventions

Ampicillin sulbactam 3 daysDRUG

Ampicillin sulbactam 1.5 gram IV BID for 3 days after CIED implantation

Placebo 3 daysDRUG

Placebo for 3 days after CIED implantation

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Kariadi Central General Hospital

Semarang, Central Java, Indonesia

Outcomes

Primary Outcomes

Incidence of CIED-related infection

Incidence of superficial infection, pocket infection, infective endocarditis, or rehospitalization

Time frame: Baseline, 3 days, 7 days, and 28 days

Secondary Outcomes

Level of Presepsin

Delta level of Presepsin

Time frame: Baseline and 24 hours after CIED implantation

Level of Interleukin-6

Delta level of Interleukin-6

Time frame: Baseline and 24 hours after CIED implantation

Level of Procalcitonin

Delta level of Procalcitonin

Time frame: Baseline and 24 hours after CIED implantation

Data from ClinicalTrials.gov

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