Central Venous CatheterNCT05124821
Evaluation of Performance Over Dwell Time and Safety of the Central-venous Catheters Certofix® Paed
An observational study of Central Venous Catheter, run by B. Braun Melsungen AG at 3 sites in 2 countries.
Trial summary
Central venous catheterisation is a medical technique that has become established over many decades and can be rated as State of the Art. However, there is only few clinical evidence for the use of Certofix® Paed and additional clinical data need to be collected to underline the long-term performance and safety in… Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Central Venous Catheter
- What is being tested?
- Central venous catheter intended to be used for children during routine clinical practice
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 May 2023to 22 Apr 2024
- 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 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Paediatric patients in need for short-term (≤ 30 days) catheterisation of the superior vena cava using the Seldinger technique for infusion and volume therapy or parenteral nutrition, for administration of highly osmolar or very vein-irritating solutions/drugs, for continuous or intermittent monitoring of the central venous pressure, for blood sampling, or when peripheral venous puncture is not possible in state of shock, in patients with injured extremities or no detectable peripheral veins.
Who may be able to join
- Written informed assent from patients as well as written informed consent from legal representatives / parents (as applicable)
- Patient's first catheter placement during current hospital stay
- Placement of catheter according to IFU (Instruction for Use)
Who cannot join
- Contraindications according to IFU
- Patient has a documented or known allergy/sensitivity to a medical adhesive product such as transparent film, adhesive dressing, tapes or liquid skin protectants
- Inclusion in another interventional study in the field of central-venous catheters which could interfere with the routine clinical practice regarding the application and care of the product until removal
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Italy2 sites
Istituto Giannina Gaslini, Anesthesia and Acute and Procedural Pain Therapy
Genova, 16147
Ospedale de Bambini Vittore Buzzi
Milan, 20154
Germany1 site
Medizinische Hochschule Hannover, Klinik für Pädiatrische Kardiologie und Pädiatrische Intensivmedizin
Hanover, 30625
About this study
Central venous catheterisation is a medical technique that has become established over many decades and can be rated as State of the Art. However, there is only few clinical evidence for the use of Certofix® Paed and additional clinical data need to be collected to underline the long-term performance and safety in paediatric patients. An updated summary overview of Binninger and Roschke describes the potential incidence rates of the classically catheter-related complications, e.g. catheter malposition, catheter fracture, occlusion, thrombosis and catheter-related bloodstream infections (CRBSI) which may have an impact on overall morbidity, mortality and treatment costs. These catheter-related complications should be evaluated in this non-interventional study in paediatric patients.
- Conditions
- Central Venous Catheter
- Being tested
- Central venous catheter intended to be used for children during routine clinical practice
- Keywords
- Central Venous Catheter, Paediatrics, Post Marketing Clinical Follow-up, Seldinger Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central venous catheter intended to be used for children during routine clinical practiceDevice
Also called Certofix® Paed
Device will applied according to instruction for use (IFU) and respective indication during routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Certofix Paed | Paediatric patients in need for short-term (≤ 30 days) catheterisation of the superior vena cava using the Seldinger technique for infusion and volume therapy or parenteral nutrition, for administration of highly osmolar or very vein-irritating solutions/drugs, for continuous or intermittent monitoring of the central venous pressure, for blood sampling, or when peripheral venous puncture is not possible in state of shock, in patients with injured extremities or no detectable peripheral veins. Receives: Device: Central venous catheter intended to be used for children during routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late complications
Incidence of thrombosis
Measured: up to 30 days
Late complications
Incidence of occlusion
Measured: up to 30 days
Late complications
Incidence of catheter insertion site infection
Measured: up to 30 days
Late complications
Incidence of malpositioning of catheter due to dislodgement or migration
Measured: up to 30 days
Secondary outcomes (30)
Early complications of central venous catheter application
Measured: Up to 2 hours
Incidence of systemic infection
Measured: up to 30 days
Catheter handling details
Number of emergency applications of the catheter
Measured: up to 30 days
Catheter handling details
Reason for insertion of catheter: infusion and volume therapy, parenteral nutrition, administration of highly osmolar solutions, administration of very vein-irritating solutions, continuous or intermittent monitoring of the central venous pressure, peripheral venous puncture was not successful or veins not detectable
Measured: up to 30 days
Catheter handling details
Place of positioning of catheter
Measured: up to 30 days
Catheter handling details
Ultrasound guided central venous catheter application
Measured: up to 30 days
Catheter handling details
Control of catheter positioning: radiologic, ECG
Measured: up to 30 days
Catheter handling details
Date of catheter insertion and removal
Measured: up to 30 days
Catheter handling details
Time of catheter insertion and removal
Measured: up to 30 days
Catheter handling details
Catheter fixation
Measured: up to 30 days
Catheter handling details
Catheter Care
Measured: up to 30 days
Catheter handling details
Observations on catheter quality
Measured: up to 30 days
Concomitant medication
Use of antibiotics or other relevant medication
Measured: up to 30 days
Adverse Device Effect (ADE)
Measured: up to 30 days
Device Deficiency (DD)
Device deficiency
Measured: up to 30 days
Device Deficiency (DD)
Duration of device deficiency
Measured: up to 30 days
Device Deficiency (DD)
Action taken
Measured: up to 30 days
Serious Adverse Event (SAE)
Measured: up to 30 days
Serious Adverse Device Effect (SADE)
Measured: up to 30 days
Catheter variables
Number of lumen
Measured: up to 30 days
Catheter variables
Size
Measured: up to 30 days
Catheter variables
Length
Measured: up to 30 days
Reason for removal of catheter
Regular end of infusion therapy or removal according to local standards
Measured: up to 30 days
Reason for removal of catheter
Upcoming sings of infection on puncture site: skin reddening, swelling, pain, increased skin temperature, fever with unclear origin, other
Measured: up to 30 days
Reason for removal of catheter
Early complication
Measured: up to 30 days
Reason for removal of catheter
Late complication
Measured: up to 30 days
Reason for removal of catheter
Technical problems with the catheter
Measured: up to 30 days
Demographic data
Age
Measured: Prior study start
Demographic data
Sex
Measured: Prior study start
Demographic data
Ethnicity
Measured: Prior study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start19 May 2023
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CatheterStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Sasse, Dr. med., Study chair, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124821
- Sponsor's protocol ID
- HC-O-H-2001
- Status last verified
- Jun 2024
- First submitted
- 12 Oct 2021
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance Over Dwell Time and Safety of the Central-venous Catheters Certofix® Paed
- ClinicalTrials.gov ID
- NCT05124821
- Acronym / sponsor ID
- HC-O-H-2001
- Conditions
- Central Venous Catheter
- Keywords
- Central Venous Catheter, Paediatrics, Post Marketing Clinical Follow-up, Seldinger Technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- 19 May 2023 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 18 Nov 2021 (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.
Central venous catheterisation is a medical technique that has become established over many decades and can be rated as State of the Art. However, there is only few clinical evidence for the use of Certofix® Paed and additional clinical data need to be collected to underline the long-term performance and safety in paediatric patients. An updated summary overview of Binninger and Roschke describes the potential incidence rates of the classically catheter-related complications, e.g. catheter malposition, catheter fracture, occlusion, thrombosis and catheter-related bloodstream infections (CRBSI) which may have an impact on overall morbidity, mortality and treatment costs. These catheter-related complications should be evaluated in this non-interventional study in paediatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Certofix Paed | – | Device: Central venous catheter intended to be used for children during routine clinical practicePaediatric patients in need for short-term (≤ 30 days) catheterisation of the superior vena cava using the Seldinger technique for infusion and volume therapy or parenteral nutrition, for administration of highly osmolar or very vein-irritating solutions/drugs, for continuous or intermittent monitoring of the central venous pressure, for blood sampling, or when peripheral venous puncture is not possible in state of shock, in patients with injured extremities or no detectable peripheral veins. |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Paediatric patients in need for short-term (≤ 30 days) catheterisation of the superior vena cava using the Seldinger technique for infusion and volume therapy or parenteral nutrition, for administration of highly osmolar or very vein-irritating solutions/drugs, for continuous or intermittent monitoring of the central venous pressure, for blood sampling, or when peripheral venous puncture is not possible in state of shock, in patients with injured extremities or no detectable peripheral veins.
Key inclusion criteria (3 listed)
- Written informed assent from patients as well as written informed consent from legal representatives / parents (as applicable)
- Patient's first catheter placement during current hospital stay
- Placement of catheter according to IFU (Instruction for Use)
Key exclusion criteria (3 listed)
- Contraindications according to IFU
- Patient has a documented or known allergy/sensitivity to a medical adhesive product such as transparent film, adhesive dressing, tapes or liquid skin protectants
- Inclusion in another interventional study in the field of central-venous catheters which could interfere with the routine clinical practice regarding the application and care of the product until removal
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 |
|---|---|---|
| Central venous catheter intended to be used for children during routine clinical practiceAlso: Certofix® PaedDevice will applied according to instruction for use (IFU) and respective indication during routine clinical practice. | Device | Certofix Paed |
Primary outcome
Late complications
Time frame: up to 30 days
Incidence of thrombosis
Late complications
Time frame: up to 30 days
Incidence of occlusion
Late complications
Time frame: up to 30 days
Incidence of catheter insertion site infection
Late complications
Time frame: up to 30 days
Incidence of malpositioning of catheter due to dislodgement or migration
30 secondary outcomes
Early complications of central venous catheter application
Time frame: Up to 2 hours
Incidence of systemic infection
Time frame: up to 30 days
Catheter handling details
Time frame: up to 30 days
Catheter handling details
Time frame: up to 30 days
Catheter handling details
Time frame: up to 30 days
Catheter handling details
Time frame: up to 30 days
Catheter handling details
Time frame: up to 30 days
Catheter handling details
Time frame: up to 30 days
Catheter handling details
Time frame: up to 30 days
Catheter handling details
Time frame: up to 30 days
Catheter handling details
Time frame: up to 30 days
Catheter handling details
Time frame: up to 30 days
Concomitant medication
Time frame: up to 30 days
Adverse Device Effect (ADE)
Time frame: up to 30 days
Device Deficiency (DD)
Time frame: up to 30 days
Device Deficiency (DD)
Time frame: up to 30 days
Device Deficiency (DD)
Time frame: up to 30 days
Serious Adverse Event (SAE)
Time frame: up to 30 days
Serious Adverse Device Effect (SADE)
Time frame: up to 30 days
Catheter variables
Time frame: up to 30 days
Catheter variables
Time frame: up to 30 days
Catheter variables
Time frame: up to 30 days
Reason for removal of catheter
Time frame: up to 30 days
Reason for removal of catheter
Time frame: up to 30 days
Reason for removal of catheter
Time frame: up to 30 days
Reason for removal of catheter
Time frame: up to 30 days
Reason for removal of catheter
Time frame: up to 30 days
Demographic data
Time frame: Prior study start
Demographic data
Time frame: Prior study start
Demographic data
Time frame: Prior study start
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 13 Jun 2024.
- 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.
Michael Sasse, Dr. med. study chair
Hannover Medical School
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Venous Catheter, run by B. Braun Melsungen AG at 3 sites in 2 countries.
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 3 inclusion and 3 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, 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?
Late complications (time frame: up to 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2024.