Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection

NCT05576194 | Completed DMC

• 1 other identifier: 19059
• Study Type: observational
• Target: 1,417
• Locations: 1 country
• Sites: 1

Brief Summary

From January 1st 2020, any CIED procedure conducted with adjunct TauroPace™ CIED and pocket irrigation is enrolled in a consecutive manner and followed up in one centre. Follow-up is prospectively. Before that date any CIED procedure conducted with adjunct antispetic pocket and CIED irrigation is evaluated retrospectively to form a comparable group.

Conditions

Cardiac Implantable Electronic Device Infection

Keywords

cardiac implantable electronic device infection, taurolidine

Outcome Measures

Primary Outcomes (1)

• CIED infection

  cardiac implantable electronic device infection

  three months

Secondary Outcomes (4)

• all cause mortality

  three months

• adverse events grade 3-5

  three months

• all cause mortality

  36 months

• adverse events grade 3-5

  36 months

Study Arms (2)

TauroPace irrigation group

every consecutive CIED placement, revision, extraction conducted with TauroPace

Device: TauroPace

antiseptic irrigation group

every procedure conducted with adjunct antiseptic irrigation, which could be Taurolidine, TauroPace or Hydrogen Peroxide 3%

Device: TauroPace; Device: Hydrogen Peroxide; Drug: Taurolidine

Interventions

TauroPace DEVICE

All the hardware (leads, suture sleeves, pulse generator) is washed and the device pocket irrigated with an adjunct antimicrobial solution containing Taurolidine (TauroPace™, Tauropharm, Bavaria, Germany), during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system since January 2019

TauroPace irrigation group; antiseptic irrigation group

Hydrogen Peroxide DEVICE

All the hardware (leads, suture sleeves, pulse generator) was washed and the device pocket irrigated with an adjunct antimicrobial solution containing 3% hydrogen peroxide (H2O2) during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system at the authors' institute before 01/01/2020

antiseptic irrigation group

Taurolidine DRUG

All the hardware (leads, suture sleeves, pulse generator) was washed and the device pocket irrigated with an adjunct antimicrobial solution containing taurolidine in a galenic formulation during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system at the authors' institute before 01/01/2019

antiseptic irrigation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The intervention group consists of every consecutive patient eligible for any CIED related surgical procedure in the centre of the investigation from January 2020 through February 2022 onwards.

You may qualify if:

• CIED procedure, signs PIC

You may not qualify if:

• PIC not signed, minor

Sponsors & Collaborators

• Prof. Dr. Hendrik Bonnemeier: lead
• University of Luebeck: collaborator

Study Sites (1)

Lakumed

Landshut, Bavaria, 84036, Germany

Location

Related Publications (4)

• Borov, S., Baldauf, B., Lau, E.W. et al. Salvage of infected cardiac implantable electronic device with taurolidine-a case report. Cardiothorac Surg 30, 7 (2022). https://doi.org/10.1186/s43057-022-00068-5

  BACKGROUND

• Giaccardi M, Baldauf B, Lau EW, Borov S, Bonnemeier H. Salvage of Cardiac Implantable Electronic Device Pocket Infection with Skin Erosion in Frail 92-Year-Old. J Cardiovasc Dev Dis. 2022 Mar 10;9(3):81. doi: 10.3390/jcdd9030081.

  PMID: 35323629 BACKGROUND

• Weichsel J, Baldauf B, Bonnemeier H, Lau EW, Dittrich S, Cesnjevar R. Eradication of Ventricular Assist Device Driveline Infection in Paediatric Patients with Taurolidine. J Cardiovasc Dev Dis. 2022 Jan 10;9(1):18. doi: 10.3390/jcdd9010018.

  PMID: 35050228 BACKGROUND

• Borov S, Baldauf B, Henke J, Pavaci H, Perani A, Zrenner B, Dietl J, Mehilli J, Lau EW, Vonthein R, Bonnemeier H. Use of a taurolidine containing antimicrobial wash to reduce cardiac implantable electronic device infection. Europace. 2023 Oct 5;25(10):euad306. doi: 10.1093/europace/euad306.

  PMID: 37831737 DERIVED

MeSH Terms

Interventions

taurolidine

Study Officials

• Stefan Borov, MD

  Lakumed Landshut, CAU Kiel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating principal investigator

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 12, 2022
• Study Start: January 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)