Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation

Pacemaker Complication Clinical Trial

— PACE-PRO  

Official title:

Comparison Effect Between a Single Dose Prophylaxis Antibiotics Given One Day and Three Days Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation: a Preliminary Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06355115
• Other study ID #: 400/218/K.3/302/2023
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: University of Brawijaya
• Contact: Icmi D Rochmawati, M.D.
• Phone: +62 857-6822-8899
• Email: icmidianr[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The insertion of a permanent pacemaker (PPM) is frequently a life-saving procedure. However, the implantation process could sometimes lead to a rare but serious infection. Therefore, administering prophylactic antibiotics to prevent infections before they occur, is a useful strategy to lower the risk of such infections.

Nonetheless, the optimal duration of prophylactic antibiotics for PPM remains uncertain. Individual study results are ambiguous and debatable due to the fact that each center has its own policy governing the regimen for prophylactic antibiotic use. Accordingly, the goal of this clinical trial is to assess and compare the effectiveness of two types of widely used prophylactic antibiotic durations in relation to the risk of infections following PPM implantations.

The main questions it aims to answer are:

1. What is the efficacy of different durations of prophylactic antibiotics (single dosage vs 3-day dosage) in preventing infective complications following PPM implantations?

2. What factors may influence the optimum use of prophylactic antibiotics for individual patients undergoing PPM implantation to minimize the risk of infective complications?

Researchers will compare a single dosage vs a 3-day dosage of prophylactic antibiotics following the PPM implantation procedure to see the risk of device-related infections.

Participants will:

• Be given a single-dose or 3-days dose of antibiotic regarding the PPM installations.

• Visit the clinic for follow-ups and tests.

Description:

The insertion of a permanent pacemaker (PPM) is a critical intervention often performed to manage various cardiac rhythm disorders, thereby enhancing patient survival and quality of life. However, the procedure carries a risk of introducing infections, which, although infrequent, can lead to severe complications. Prophylactic administration of antibiotics has been recognized as an effective measure to mitigate this risk by preventing the onset of infections prior to their occurrence.

Despite the widespread acceptance of this practice, the optimal duration of antibiotic prophylaxis for PPM implantation remains a subject of debate. Variability in clinical protocols across different healthcare centers further complicates the establishment of a standardized approach. This clinical trial is designed to address this gap by evaluating and comparing the efficacy of two commonly employed prophylactic antibiotic regimens - a single dose versus a three-day course - in reducing the incidence of infectious complications following PPM implantations.

The study aims to address the following research questions:

1. What is the comparative effectiveness of a single dose versus a three-day course of prophylactic antibiotics in preventing infectious complications after PPM implantation?

2. What patient-specific or procedural factors might influence the optimal choice and duration of prophylactic antibiotic therapy in the context of PPM implantation?

To achieve these objectives, the trial will enroll patients scheduled for PPM implantation and randomly assign them to receive either a single dose or a three-day course of antibiotics. The choice of antibiotic will be based on our institutional guidelines, i.e. 1 gram of intravenous Cefazolin (first-generation cephalosporins), and by considering the patient's allergy history. The primary outcome will be the occurrence of device-related infections within a specified follow-up period, assessed through clinical examinations, laboratory tests, and imaging studies.

Participants will be required to attend follow-up visits at designated intervals post-implantation for assessment of any signs of infection, wound healing, and device function. Adherence to the antibiotic regimen and any adverse reactions will also be monitored.

By systematically comparing the outcomes of the two antibiotic regimens, this study aims to provide evidence-based guidance for the optimization of prophylactic antibiotic use in PPM implantations, thereby enhancing patient safety and treatment efficacy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

Case inclusion criteria

1. Adult patients, aged 18 to 100 years old, with indications for PPM (single or double chamber) installation.

2. The patient is scheduled to undergo PPM installation for the first time

3. The patient is willing to undergo routine follow-ups and visits

4. Patients who are medically stable and do not have any acute illnesses that could interfere with the study outcomes.

Exclusion Criteria:

1. Patients with fever before the Procedure

2. Skin disease

3. Patients on anticoagulants or receiving bridging heparin

4. Patients who used antibiotics 30 days before the PPM installation was carried out

5. Patients with end stage renal failure

6. Patients with uncontrolled Diabetes Mellitus

7. Patients with a history of infective endocarditis

8. Patients with a history of moderate to severe valvular heart disease

9. Patients with congenital heart disease

10. Patients with non-cardiac comorbid diseases whose life expectancy is < 1 year

11. Illness or physical disorder that causes the patient to be unable or limited to carry out physical activities

12. Patients with a history of autoimmune disease, and confirmed autoimmune disease

13. Patients on long-term steroid use

14. The patient refused follow-up

Related Conditions & MeSH terms

• Infections
• Pacemaker Complication

Intervention

Drug:
• Cefazolin 1000 MG Injection
Cefazolin 1000 mg given intravenously

Locations

Country	Name	City	State
Indonesia	RSUD Dr. Saiful Anwar	Malang	Jawa Timur

Sponsors (2)

Lead Sponsor	Collaborator
University of Brawijaya	Saiful Anwar Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with early pocket infection (EPI)	EPI refers to a post-operative complication characterized by wound infection or infection of the device pouch within the initial weeks or month following surgical procedure. Manifestations of early pocket infections include local signs of inflammation such as erythema, edema, warmth, and tenderness at the implantation site, occasionally accompanied by purulent discharge or systemic symptoms such as fever.	0-30 days
Primary	Number of participants with late pocket infection (LPI)	LPI refers to a post-operative complication characterized by wound infection or infection of the device pouch within the following months following surgical procedure. Manifestations of late pocket infections are similar to those of EPI, which include local signs of inflammation such as erythema, edema, warmth, and tenderness at the implantation site, occasionally accompanied by purulent discharge or systemic symptoms such as fever.	1-3 months
Primary	Number of participants with infective endocarditis (IE)	IE following the implantation of PPM is characterized by bacteremia due to device infection, lead vegetation, right infective endocarditis. Diagnosis is established through history taking and physical examination and the visualization of vegetations by Transthoracic Echocardiography (TTE).	1 year
Primary	Number of participants who underwent pacemaker revision	Pacemaker revision or reimplantation due to infective complications.	1 year
Secondary	Level of C-reactive protein (mg/dl)	C-reactive protein (CRP) levels will be measured from venous blood samples obtained from patients on the third day following the PPM implantation procedure.	3 days
Secondary	Level of procalcitonin (mcg/dl)	Procalcitonin (PCT) levels will be measured from venous blood samples obtained from patients on the third day following the PPM implantation procedure.	3 days
Secondary	Erythrocyte sedimentation rate (ESR) (mm/hour)	Erythrocyte sedimentation rate (ESR) levels will be measured from venous blood samples obtained from patients on the third day following the PPM implantation procedure.	3 days
Secondary	Neutrophil-to-leukocyte ratio (NLR)	Neutrophil-to-leukocyte ratio (NLR) levels will be measured from venous blood samples obtained from patients on the third day following the PPM implantation procedure.	3 days
Secondary	Neutrophil count (cells/mm3)	Neutrophil count levels will be measured from venous blood samples obtained from patients as part of complete blood count testing, on the third day following the PPM implantation procedure.	3 days
Secondary	Leukocyte count (cells/mm3)	Leukocyte (white blood cells) count levels will be measured from venous blood samples obtained from patients as part of complete blood count testing, on the third day following the PPM implantation procedure.	3 days