Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey

Completed

• Conditions: Antibiotic Prophylaxis; Adult Heart Transplantation
• Interventions: Procedure: Antibiotic prophylaxis in adult heart transplantation

• Registration Number: NCT02479503
• Lead Sponsor: University Hospital, Caen

Brief Summary

The study focuses on the antibiotic prophylaxis use in adult heart transplantation in France.

Detailed Description

In adult heart transplantation, clinical situations differ between patients (elective, emergency, redux surgery, ventricular assisting device or extracorporeal live saving). At investigator's knowledge, there is not recommendations in France about antibiotic prophylaxis in adult heart transplantation. So, investigators aimed to study the antibiotic prophylaxis use in adult heart transplantation in France.

Investigators conduct a French national survey about antibiotic prophylaxis used in adult heart transplantation center. Clinical situations such as elective, emergency, redux surgery, ventricular assisting device or extracorporeal live saving are investigated.

Study was performed after Institutional approval was obtained from the local Ethics Committee (Comite de Protection des Personnes Nord Ouest III). An electronic survey was sent to all French adult heart transplantation centers (22) on march 1st, 2015. Reminders were planned on week 2 and 4 after initial sending. On june 2015, nonresponding centers were contacted by phone. Data were collected by a single investigator.

Study Timeline

• Study Start: 2015-03
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-24
• Study Completion: 2015-07
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• All French centers performing adult heart transplantation in 2015

Exclusion Criteria

• not responding center
• no adult heart transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
French Adult Heart Transplantation Center	Antibiotic prophylaxis in adult heart transplantation	All center performing adult heart transplantation in France in 2015.

Primary Outcome Measures

Name	Time	Method
Class of antibiotic used as prophylaxis in adult heart transplantation	one year

Secondary Outcome Measures

Name	Time	Method
Class of antibiotic used as prophylaxis in adult heart transplantation in regard to clinical situation	one year	elective, emergency, redux surgery, ventricular assisting device or extracorporeal live saving
Fungal prophylaxis in adult heart transplantation	one year
Other prophylactic measures (isolation, specific room, family visits) used in adult heart transplantation	one year

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, Normandy, France