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OpenTrials
Completed

NCT Number: NCT06448624

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

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

Completed

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Key information

Conditions

Heart Block Antibiotic Prophylaxis Arrhythmias, Cardiac Biomarkers CIED Related Infection CIED-related Infections Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kariadi Central General Hospital

Semarang, Central Java, 50244, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ampicillin sulbactam 3 days

Drug

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

Placebo 3 days

Drug

Placebo for 3 days after CIED implantation

Primary outcomes

  1. Incidence of CIED-related infection

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

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

Secondary outcomes

  1. Level of Presepsin

    Time frame: Baseline and 24 hours after CIED implantation

    Delta level of Presepsin

  2. Level of Interleukin-6

    Time frame: Baseline and 24 hours after CIED implantation

    Delta level of Interleukin-6

  3. Level of Procalcitonin

    Time frame: Baseline and 24 hours after CIED implantation

    Delta level of Procalcitonin

Sponsors and collaborators

Lead sponsor

Universitas Diponegoro

Other

Collaborators

  • Dr. Kariadi General Hospital Medical Center

Registry information

Official study title

Effect of Single Dose & Intrapocket Prophylactic Antibiotic to Cardiac Implantable Electronic Device-related Infection & Biomarkers

Acronym: BI-PACED

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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