CLABSI - Central Line Associated Bloodstream InfectionNCT06365528
Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes
A study testing Subcutaneous tunnelling and Non-tunnelling in people with CLABSI - Central Line Associated Bloodstream Infection and Deep Vein Thrombosis, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLABSI - Central Line Associated Bloodstream Infection, Deep Vein Thrombosis, Dislodged Catheter
- What is being tested?
- Subcutaneous tunnelling and Non-tunnelling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteBrazil
- Study dates
- 6 May 2024to 31 Jul 2026
- 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
- adult patients (>= 18 years old) admitted to medical clinics, surgical clinics, or ICU, who have an indication for PICC insertion;
Who cannot join
- patients with Chronic Kidney Disease, whether dialytic or not;
- patients in critical or unstable condition characterized by the need for intubation, respiratory rate <8 or >35 breaths per minute, oxygen saturation <90%, heart rate <40 or >140 beats per minute, systolic blood pressure <90mmHg, decreased Glasgow Coma Scale >2 points, or prolonged (>5 minutes) or repeated seizures;
- patients with cognitive deficits that impair their understanding of the study and do not have a responsible party to assist in this stage.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre
Eneida R Rabelo da Silva, ScD
About this study
Official title: Tunneled Versus Non-Tunneled Peripherally Inserted Central Catheter and Their Effects on Reducing Combined or Isolated Outcomes (Obstruction, Infection, Thrombosis, and Dislodgement): Multicenter Randomized Clinical Trial
The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the adult population within a period of up to 30 days.
Read the detailed description
The data published this year from a multicenter study in Brazil presenting the patterns of use and clinical outcomes of PICC indicated that centers with vascular access teams, adoption of best practices, and current technologies result in low rates of complications, such as primary bloodstream infections related to the catheter, deep vein thrombosis, and reversible occlusion. Despite these more recent data showing that complications related to PICC can be mitigated by the use of technology, vascular access teams, adoption of best practices, and infection control measures, there is still room to incorporate new techniques in PICC insertion with the aim of further reducing avoidable complications. For example, recent studies with robust methodology have demonstrated the benefit of the tunneling technique compared to the conventional insertion technique. A randomized clinical trial showed that the dwell time of the device inserted using the tunneling technique was longer compared to the conventional technique without tunneling in adult patients, along with a lower incidence of thrombosis and infection. At the Hospital de Clínicas de Porto Alegre, recently, nurses from the PICC Team were trained in the tunneling technique at a reference center in Brazil. The initial results of tunneling in adult, pediatric, and neonatal patients are encouraging.
The observed results of implementing the technique indicate that there is potential to reduce avoidable complications and prompt us to propose a multicenter randomized controlled trial involving two additional institutions with similar profiles regarding the composition of Vascular Access Teams, adoption of best practices related to catheter care, and active ongoing education. To our knowledge, robust studies of this nature are not currently being conducted in Brazil.
- Conditions
- CLABSI - Central Line Associated Bloodstream Infection, Deep Vein Thrombosis, Dislodged Catheter, Occlusion, Catheter Rupture, Catheter (Other); Complications
- Being tested
- Subcutaneous tunnelling, Non-tunnelling
- Medical subject headings
- Venous Thrombosis, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous tunnellingProcedure or surgery
The Subcutaneous tunnelling group will undergo PICC placement under ultrasonography. Procedures will be implemented under hand hygiene, maximal sterile barrier, and chlorhexidine. The targeted arm will be sterilized with a mixture of chlorhexidine and isopropyl alcohol, and a sterile drape will be placed to cover the entire procedure feld from head to toe and place with additional subcutaneous tunnelling. After vein puncture with the access needle, a Nitinol guidewire will be placed as usual. We will make a tunnel distal to the initial venepuncture site using an additional 14-gauge needle. After resolution of the loop over the venepuncture site, a peel-away sheath will be placed over the wire. The catheter will be trimmed to the distance between the venepuncture site and cavoatrial junction plus the subcutaneous tunnel before being inserted in the usual manner.
Non-tunnellingProcedure or surgery
The Non-tunnelling group will have PICC placement with the traditional method under ultrasonography. Procedures will be implemented under hand hygiene, maximal sterile barrier, and chlorhexidine. The targeted arm will be sterilized with a mixture of chlorhexidine and isopropyl alcohol, and a sterile drape will be placed to cover the entire procedure feld from head to toe. After vein puncture with the access needle, a Nitinol guidewire will be placed. After, a peel-away sheath will be placed over the wire. The catheter will be trimmed to the distance between the venepuncture site and cavoatrial junction.
| Study group | Role | What they receive |
|---|---|---|
| Tunneled PICC | Experimental | The intervention group will consist of adult patients who will have PICCs inserted using the catheter tunneling technique. The technique involves the catheter being exteriorized through the skin at a site different from the blood vessel puncture site, thus traversing a subcutaneous tunnel. Receives: Procedure: Subcutaneous tunnelling |
| Non-tunneled PICC | Active comparator | The control group will consist of adults patients who will have PICCs inserted using the conventional technique Receives: Procedure: Non-tunnelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of therapy or catheter removal free from complications
Time in days
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start6 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CLABSI - Central Line Associated Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Moinhos de Vento, Irmandade Santa Casa de Misericórdia de Porto Alegre
- Responsible party
- Sponsor
- Investigators
- Eneida R Rabelo da Silva, ScD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365528
- Sponsor's protocol ID
- 2023-0232
- Status last verified
- May 2024
- First submitted
- 10 Apr 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ceratti RDN, Taxbro K, Chopra V, Hansel LA, Salini CG, Brum ID, Junges M, Dos Santos AG, Rabelo-Silva ER. Tunneled peripherally inserted central catheter versus non-tunneled and its effects in clinical outcomes: A multicenter randomized clinical trial protocol. PLoS One. 2026 Mar 10;21(3):e0342385. doi: 10.1371/journal.pone.0342385. eCollection 2026.
PubMed 41805752
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tunneled Versus Non-Tunneled Peripherally Inserted Central Catheter and Their Effects on Reducing Combined or Isolated Outcomes (Obstruction, Infection, Thrombosis, and Dislodgement): Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06365528
- Acronym / sponsor ID
- 2023-0232
- Conditions
- CLABSI - Central Line Associated Bloodstream Infection, Deep Vein Thrombosis, Dislodged Catheter, Occlusion, Catheter Rupture, Catheter (Other); Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Hospital Moinhos de Vento, Irmandade Santa Casa de Misericórdia de Porto Alegre
- Study start
- 6 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 15 Apr 2024 (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.
The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the adult population within a period of up to 30 days.
Detailed description
The data published this year from a multicenter study in Brazil presenting the patterns of use and clinical outcomes of PICC indicated that centers with vascular access teams, adoption of best practices, and current technologies result in low rates of complications, such as primary bloodstream infections related to the catheter, deep vein thrombosis, and reversible occlusion. Despite these more recent data showing that complications related to PICC can be mitigated by the use of technology, vascular access teams, adoption of best practices, and infection control measures, there is still room to incorporate new techniques in PICC insertion with the aim of further reducing avoidable complications. For example, recent studies with robust methodology have demonstrated the benefit of the tunneling technique compared to the conventional insertion technique. A randomized clinical trial showed that the dwell time of the device inserted using the tunneling technique was longer compared to the conventional technique without tunneling in adult patients, along with a lower incidence of thrombosis and infection. At the Hospital de Clínicas de Porto Alegre, recently, nurses from the PICC Team were trained in the tunneling technique at a reference center in Brazil. The initial results of tunneling in adult, pediatric, and neonatal patients are encouraging.
The observed results of implementing the technique indicate that there is potential to reduce avoidable complications and prompt us to propose a multicenter randomized controlled trial involving two additional institutions with similar profiles regarding the composition of Vascular Access Teams, adoption of best practices related to catheter care, and active ongoing education. To our knowledge, robust studies of this nature are not currently being conducted in Brazil.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tunneled PICC | Experimental | Procedure: Subcutaneous tunnellingThe intervention group will consist of adult patients who will have PICCs inserted using the catheter tunneling technique. The technique involves the catheter being exteriorized through the skin at a site different from the blood vessel puncture site, thus traversing a subcutaneous tunnel. |
| Non-tunneled PICC | Active comparator | Procedure: Non-tunnellingThe control group will consist of adults patients who will have PICCs inserted using the conventional technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients (>= 18 years old) admitted to medical clinics, surgical clinics, or ICU, who have an indication for PICC insertion;
Key exclusion criteria (3 listed)
- patients with Chronic Kidney Disease, whether dialytic or not;
- patients in critical or unstable condition characterized by the need for intubation, respiratory rate <8 or >35 breaths per minute, oxygen saturation <90%, heart rate <40 or >140 beats per minute, systolic blood pressure <90mmHg, decreased Glasgow Coma Scale >2 points, or prolonged (>5 minutes) or repeated seizures;
- patients with cognitive deficits that impair their understanding of the study and do not have a responsible party to assist in this stage.
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 |
|---|---|---|
| Subcutaneous tunnellingThe Subcutaneous tunnelling group will undergo PICC placement under ultrasonography. Procedures will be implemented under hand hygiene, maximal sterile barrier, and chlorhexidine. The targeted arm will be sterilized with a mixture of chlorhexidine and isopropyl alcohol, and a sterile drape will be placed to cover the entire procedure feld from head to toe and place with additional subcutaneous tunnelling. After vein puncture with the access needle, a Nitinol guidewire will be placed as usual. We will make a tunnel distal to the initial venepuncture site using an additional 14-gauge needle. After resolution of the loop over the venepuncture site, a peel-away sheath will be placed over the wire. The catheter will be trimmed to the distance between the venepuncture site and cavoatrial junction plus the subcutaneous tunnel before being inserted in the usual manner. | Procedure or surgery | Tunneled PICC |
| Non-tunnellingThe Non-tunnelling group will have PICC placement with the traditional method under ultrasonography. Procedures will be implemented under hand hygiene, maximal sterile barrier, and chlorhexidine. The targeted arm will be sterilized with a mixture of chlorhexidine and isopropyl alcohol, and a sterile drape will be placed to cover the entire procedure feld from head to toe. After vein puncture with the access needle, a Nitinol guidewire will be placed. After, a peel-away sheath will be placed over the wire. The catheter will be trimmed to the distance between the venepuncture site and cavoatrial junction. | Procedure or surgery | Non-tunneled PICC |
Primary outcome
End of therapy or catheter removal free from complications
Time frame: Up to 30 days
Time in days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Derived from this study: PubMed 41805752Ceratti RDN, Taxbro K, Chopra V, Hansel LA, Salini CG, Brum ID, Junges M, Dos Santos AG, Rabelo-Silva ER. Tunneled peripherally inserted central catheter versus non-tunneled and its effects in clinical outcomes: A multicenter randomized clinical trial protocol. PLoS One. 2026 Mar 10;21(3):e0342385. doi: 10.1371/journal.pone.0342385. eCollection 2026.
- 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.
Eneida R Rabelo da Silva, ScD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous tunnelling and Non-tunnelling in people with CLABSI - Central Line Associated Bloodstream Infection and Deep Vein Thrombosis, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 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: status not confirmed, as of the sponsor's last update on 20 May 2024. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eneida R Rabelo da Silva, ScD (5551998068616, eneidarabelo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End of therapy or catheter removal free from complications (time frame: Up to 30 days). 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 NCT06365528, which also lists 1 linked publication.
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 20 May 2024.