Catheter Related InfectionsPYCBACNCT02538159
Safety and Bacteraemia Between Peripherally Inserted and Central Inserted Catheters.
A study testing CVC and PICC in people with Catheter Related Infections, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Clinical, prospective, single-center, national trial. open and randomized at 1: 1 to compare the rate of bacteremia associated between non-tunneled Central venous catheter and peripheral inserted central catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Related Infections
- What is being tested?
- CVC and PICC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2015to 11 Jul 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥ 18 years.
- Patients hospitalized at our institution requiring at least 6 days of intravenous treatment in a conventional ward of our hospital.
- Signed informed consent by the patient and / or when necessary parent / legal guardian.
Who cannot join
- Patients with bacteremia at the time of catheter insertion.
- Patients admitted to hematology or intensive care units, for considered a type of patient characteristics very different from other patients.
- Patients with severe clinical situation.
- Patients in whom peripheral venous access is technically impossible, patients outpatient and express refusal of the patient.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Prospective, Single-center Study to Compare the Effectiveness and Safety in Terms of Catheter Bacteraemia, Between Peripherally Inserted Central Catheters and Non-tunneled Central Venous Catheter in Tertiary Hospital
Clinical, prospective, single-center, national trial. open and randomized at 1: 1 to compare the rate of bacteremia associated between non-tunneled Central venous catheter and peripheral inserted central catheter.
- Conditions
- Catheter Related Infections
- Being tested
- CVC, PICC
- Keywords
- Non-tunneled Central venous catheter, Bacteraemia, Peripherally inserted central venous catheter
- Medical subject headings
- Catheter-Related Infections, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVCDevice
The inclusion of any CVC is an aseptic technique, so hand washing, mask, cap is required, sterile gloves and scoping insertion using sterile drapes. The skin disinfection is carried out with 2% chlorhexidine alcohol 17, to be dried completely before insertion of the catheter (30 seconds). No prophylactic antibiotic was administered before insertion. In the case of CVC, the subclavian vein of choice will be followed by the femoral and jugular. Seldinger technique with direct radiation control in the operating room is used.
PICCDevice
The inclusion of any PICC is an aseptic technique, so hand washing, mask, cap is required, sterile gloves and scoping insertion using sterile drapes. The skin disinfection is carried out with 2% chlorhexidine alcohol 17, to be dried completely before insertion of the catheter (30 seconds). No prophylactic antibiotic was administered before insertion. PICC vein of choice is the basilica vein with help of Ecography in the interventional radiology room.
| Study group | Role | What they receive |
|---|---|---|
| Experimental CVC | Experimental | CVC insertion Non-tunneled Central venous catheter insertion Receives: Device: CVC |
| Experimental PICC | Experimental | PICC insertion Peripherally inserted catheter Receives: Device: PICC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Bacteraemia
Number of participants with Bacteraemia from insertion until 30 days after remove of the catheter
Measured: 30 days
Secondary outcomes (5)
morbidities in catheter insertion
Number of participants with complications during catheter insertion
Measured: 1 day
Comparison of morbidities during manipulation of the catheters
Number of participants with complications during manipulation of the catheters
Measured: 30 days
30 days Mortality
Number of died participants
Measured: 30 days
Visual analogic scale of Pain
Visual analogic scale of Pain in site of insertion from insertion until remove of the catheter
Measured: 30 days
Health-care costs
Economic study of the whole procedure including complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study start2 Sep 2015
- Primary completion11 Jun 2017
- Study completion11 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Related InfectionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538159
- Sponsor's protocol ID
- IIBSP-CAT-2014-36
- Acronym
- PYCBAC
- Status last verified
- Oct 2018
- First submitted
- 23 Apr 2015
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Single-center Study to Compare the Effectiveness and Safety in Terms of Catheter Bacteraemia, Between Peripherally Inserted Central Catheters and Non-tunneled Central Venous Catheter in Tertiary Hospital
- ClinicalTrials.gov ID
- NCT02538159
- Acronym / sponsor ID
- PYCBAC / IIBSP-CAT-2014-36
- Conditions
- Catheter Related Infections
- Keywords
- Non-tunneled Central venous catheter, Bacteraemia, Peripherally inserted central venous catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 2 Sep 2015 (actual)
- Primary completion
- 11 Jun 2017 (actual)
- Study completion
- 11 Jul 2017 (actual)
- First posted
- 2 Sep 2015 (estimated)
- 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.
Clinical, prospective, single-center, national trial. open and randomized at 1: 1 to compare the rate of bacteremia associated between non-tunneled Central venous catheter and peripheral inserted central catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental CVC | Experimental | Device: CVCCVC insertion Non-tunneled Central venous catheter insertion |
| Experimental PICC | Experimental | Device: PICCPICC insertion Peripherally inserted catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients ≥ 18 years.
- Patients hospitalized at our institution requiring at least 6 days of intravenous treatment in a conventional ward of our hospital.
- Signed informed consent by the patient and / or when necessary parent / legal guardian.
Key exclusion criteria (5 listed)
- Patients with bacteremia at the time of catheter insertion.
- Patients admitted to hematology or intensive care units, for considered a type of patient characteristics very different from other patients.
- Patients with severe clinical situation.
- Patients in whom peripheral venous access is technically impossible, patients outpatient and express refusal of the patient.
- Pregnant patients.
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 |
|---|---|---|
| CVCThe inclusion of any CVC is an aseptic technique, so hand washing, mask, cap is required, sterile gloves and scoping insertion using sterile drapes. The skin disinfection is carried out with 2% chlorhexidine alcohol 17, to be dried completely before insertion of the catheter (30 seconds). No prophylactic antibiotic was administered before insertion. In the case of CVC, the subclavian vein of choice will be followed by the femoral and jugular. Seldinger technique with direct radiation control in the operating room is used. | Device | Experimental CVC |
| PICCThe inclusion of any PICC is an aseptic technique, so hand washing, mask, cap is required, sterile gloves and scoping insertion using sterile drapes. The skin disinfection is carried out with 2% chlorhexidine alcohol 17, to be dried completely before insertion of the catheter (30 seconds). No prophylactic antibiotic was administered before insertion. PICC vein of choice is the basilica vein with help of Ecography in the interventional radiology room. | Device | Experimental PICC |
Primary outcome
Number of participants with Bacteraemia
Time frame: 30 days
Number of participants with Bacteraemia from insertion until 30 days after remove of the catheter
5 secondary outcomes
morbidities in catheter insertion
Time frame: 1 day
Comparison of morbidities during manipulation of the catheters
Time frame: 30 days
30 days Mortality
Time frame: 30 days
Visual analogic scale of Pain
Time frame: 30 days
Health-care costs
Time frame: 30 days
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 25 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVC and PICC in people with Catheter Related Infections, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 5 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 25 Oct 2018. 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 Spain. 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?
Number of participants with Bacteraemia (time frame: 30 days). 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 25 Oct 2018.