Cardiac Implantable Electronic Device InfectionNCT05576194
Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection
An observational study of Cardiac Implantable Electronic Device Infection, run by Prof. Dr. Hendrik Bonnemeier at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Implantable Electronic Device Infection
- What is being tested?
- TauroPace, Hydrogen Peroxide and Taurolidine
- Type of treatment
- Medical device
- How many people
- 1,417 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2020to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- CIED procedure, signs PIC
Who cannot join
- PIC not signed, minor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intraoperative Topical Application of a Taurolidine Solution on CIED Related Infections in the Clinical Setting - a Prospective Observational Study With a Restrospective Historical Control
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.
Read the detailed description
All the hardware (leads, suture sleeves, pulse generator) is washed and the device pocket irrigated with an adjunct antimicrobial solution, which could be 3% hydrogen peroxide (H2O2), taurolidine in a galenic formulation or TauroPace™ (TP, 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 at the authors' institute. Before 01/01/2020, the choice of antimicrobial solution was at the operator's discretion. These procedures were evaluated retrospectively. With change of policy on the first of January 2020, in every consecutive patient and procedure only TP is used. Patients were enrolled and followed consecutively in order of appearance. All CIED procedures performed at the author's institute between 01/01/2017 and 28/02/2022 are included for analysis. Patients who receive the galenic taurolidine formulation were excluded from analysis.
- Being tested
- TauroPace, Hydrogen Peroxide, Taurolidine
- Keywords
- cardiac implantable electronic device infection, taurolidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TauroPaceDevice
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
Hydrogen PeroxideDevice
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
TaurolidineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| TauroPace irrigation group | every consecutive CIED placement, revision, extraction conducted with TauroPace Receives: Device: TauroPace | |
| antiseptic irrigation group | every procedure conducted with adjunct antiseptic irrigation, which could be Taurolidine, TauroPace or Hydrogen Peroxide 3% Receives: Device: TauroPace; Device: Hydrogen Peroxide; Drug: Taurolidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIED infection
cardiac implantable electronic device infection
Measured: three months
Secondary outcomes (4)
all cause mortality
death of any cause during the observation
Measured: three months
adverse events grade 3-5
adverse events related to CIED, procedure or the atiseptic used
Measured: three months
all cause mortality
death of any cause during all of the follow up period
Measured: 36 months
adverse events grade 3-5
adverse events related to CIED, procedure or the atiseptic used during all of the follow-up period
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Jan 2020
- Primary completion1 Mar 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac Implantable Electronic Device InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Hendrik Bonnemeier
- Sponsor type
- University, hospital or other
- Collaborators
- University of Luebeck
- Responsible party
- Sponsor-investigator, Prof. Dr. Hendrik Bonnemeier, University of Kiel
- Investigators
- Stefan Borov, MD, Principal investigator, Lakumed Landshut, CAU Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576194
- Sponsor's protocol ID
- 19059
- Status last verified
- Nov 2023
- First submitted
- 5 Oct 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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.
PubMed 35323629Weichsel 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.
PubMed 35050228Borov 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.
PubMed 37831737
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Topical Application of a Taurolidine Solution on CIED Related Infections in the Clinical Setting - a Prospective Observational Study With a Restrospective Historical Control
- ClinicalTrials.gov ID
- NCT05576194
- Acronym / sponsor ID
- 19059
- Keywords
- cardiac implantable electronic device infection, taurolidine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,417 participants (actual)
- Lead sponsor
- Prof. Dr. Hendrik BonnemeierUniversity, hospital or other
- Collaborators
- University of Luebeck
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All the hardware (leads, suture sleeves, pulse generator) is washed and the device pocket irrigated with an adjunct antimicrobial solution, which could be 3% hydrogen peroxide (H2O2), taurolidine in a galenic formulation or TauroPace™ (TP, 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 at the authors' institute. Before 01/01/2020, the choice of antimicrobial solution was at the operator's discretion. These procedures were evaluated retrospectively. With change of policy on the first of January 2020, in every consecutive patient and procedure only TP is used. Patients were enrolled and followed consecutively in order of appearance. All CIED procedures performed at the author's institute between 01/01/2017 and 28/02/2022 are included for analysis. Patients who receive the galenic taurolidine formulation were excluded from analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TauroPace irrigation group | – | Device: TauroPaceevery consecutive CIED placement, revision, extraction conducted with TauroPace |
| antiseptic irrigation group | – | Device: TauroPace, Device: Hydrogen Peroxide, Drug: Taurolidineevery procedure conducted with adjunct antiseptic irrigation, which could be Taurolidine, TauroPace or Hydrogen Peroxide 3% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- CIED procedure, signs PIC
Key exclusion criteria (1 listed)
- PIC not signed, minor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TauroPaceAll 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 | Device | TauroPace irrigation group, antiseptic irrigation group |
| Hydrogen PeroxideAll 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 | Device | antiseptic irrigation group |
| TaurolidineAll 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 | Drug | antiseptic irrigation group |
Primary outcome
CIED infection
Time frame: three months
cardiac implantable electronic device infection
4 secondary outcomes
all cause mortality
Time frame: three months
adverse events grade 3-5
Time frame: three months
all cause mortality
Time frame: 36 months
adverse events grade 3-5
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- BackgroundBorov, 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: PubMed 35323629Giaccardi 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.
- Background: PubMed 35050228Weichsel 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.
- Derived from this study: PubMed 37831737Borov 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Borov, MD principal investigator
Lakumed Landshut, CAU Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Implantable Electronic Device Infection, run by Prof. Dr. Hendrik Bonnemeier at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIED infection (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05576194, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.