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

Phase 4

Completed

• Conditions: Heart Block; Biomarkers; CIED-related Infections; CIED Related Infection; Antibiotic Prophylaxis
• Interventions: Drug: Placebo 3 days; Drug: Ampicillin sulbactam 3 days

• Registration Number: NCT06448624
• Lead Sponsor: Universitas Diponegoro

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-06-02
• Study First Posted: 2024-06-07
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Placebo 3 days	Ampicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + placebo for 3 days after implantation
Control	Ampicillin sulbactam 3 days	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

Primary Outcome Measures

Name	Time	Method
Incidence of CIED-related infection	Baseline, 3 days, 7 days, and 28 days	Incidence of superficial infection, pocket infection, infective endocarditis, or rehospitalization

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kariadi Central General Hospital; 🇮🇩 Semarang, Central Java, Indonesia