Bacterial InfectionsNCT01638702
Study of Complication Rates Associated With PICC for Left vs Right
A study testing Follow up of complications in people with Bacterial Infections, run by Richard Lindsay at 2 sites in Canada.
Trial summary
Peripherally inserted central catheter (PICC) are catheters that are placed mainly in the arms, but which pass in the veins to beside the heart. They are associated with occasional complications due to infection or blockage of the vein that they are in. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Follow up of complications
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2012to Sep 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral for in-patient PICC placement at centre carrying out study.
Who cannot join
- Out of hospital referrals for PICC placement; previous PICC placement; previous long term central catheter/pacemaker; unable to give valid consent; presence of pre-existing medical preventing randomisation.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Royal Victoria Hospital
Montreal, Quebec, H4A 3J1
About this study
Official title: Assessment of Impact of Choice of Arm for Access on Rate of Complications in Peripherally Inserted Central Venous Catheters
Peripherally inserted central catheter (PICC) are catheters that are placed mainly in the arms, but which pass in the veins to beside the heart. They are associated with occasional complications due to infection or blockage of the vein that they are in. The investigators want to investigate whether PICCs in the right arm have lower complications than those in the left. This difference in complication rates has been noticed in most other forms of central venous access.
- Conditions
- Bacterial Infections
- Being tested
- Follow up of complications
- Keywords
- Catheterisation, Central Venous, Catheters, Indwelling
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up of complicationsOther
Follow up for complications leading or not to removal (occlusion, accidental removal, infection, catheter related thrombosis, leaking, pain...)
| Study group | Role | What they receive |
|---|---|---|
| Right sided PICC placement | Active comparator | Insertion of PICC on the right arm Receives: Other: Follow up of complications |
| Left sided arm placement | Placebo comparator | Insertion of PICC on the left arm Receives: Other: Follow up of complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Line infection rate
All patients will be followed from the point of time of randomisation and PICC insertion until the line develops a complication or is removed. The average length of duration of line access in our institution is 4 weeks.
Measured: From insertion to line removal, an estimated time of 4 weeks
Secondary outcomes (1)
Effect of number of lumens
Assessing the effect number of lumens in the catheter has on complication rate.
Measured: From insertion to time of removal, an estimated average time of four weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Lindsay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Richard Lindsay, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Richard Lindsay, MB Bch BaO, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreFrance Paquet, BS(N) MS(N), Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638702
- Sponsor's protocol ID
- 12-086-BMB
- Status last verified
- Mar 2016
- First submitted
- 18 Jun 2012
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Impact of Choice of Arm for Access on Rate of Complications in Peripherally Inserted Central Venous Catheters
- ClinicalTrials.gov ID
- NCT01638702
- Acronym / sponsor ID
- 12-086-BMB
- Conditions
- Bacterial Infections
- Keywords
- Catheterisation, Central Venous, Catheters, Indwelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Richard LindsayUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 Jul 2012 (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.
Peripherally inserted central catheter (PICC) are catheters that are placed mainly in the arms, but which pass in the veins to beside the heart. They are associated with occasional complications due to infection or blockage of the vein that they are in. The investigators want to investigate whether PICCs in the right arm have lower complications than those in the left. This difference in complication rates has been noticed in most other forms of central venous access.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right sided PICC placement | Active comparator | Other: Follow up of complicationsInsertion of PICC on the right arm |
| Left sided arm placement | Placebo comparator | Other: Follow up of complicationsInsertion of PICC on the left arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referral for in-patient PICC placement at centre carrying out study.
Key exclusion criteria (1 listed)
- Out of hospital referrals for PICC placement; previous PICC placement; previous long term central catheter/pacemaker; unable to give valid consent; presence of pre-existing medical preventing randomisation.
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 |
|---|---|---|
| Follow up of complicationsFollow up for complications leading or not to removal (occlusion, accidental removal, infection, catheter related thrombosis, leaking, pain...) | Other | Left sided arm placement, Right sided PICC placement |
Primary outcome
Line infection rate
Time frame: From insertion to line removal, an estimated time of 4 weeks
All patients will be followed from the point of time of randomisation and PICC insertion until the line develops a complication or is removed. The average length of duration of line access in our institution is 4 weeks.
1 secondary outcome
Effect of number of lumens
Time frame: From insertion to time of removal, an estimated average time of four weeks.
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 16 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
Richard Lindsay, MB Bch BaO principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
France Paquet, BS(N) MS(N) principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow up of complications in people with Bacterial Infections, run by Richard Lindsay at 2 sites in Canada.
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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. 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?
Line infection rate (time frame: From insertion to line removal, an estimated time of 4 weeks). 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 16 Mar 2016.