Critical Care3SITESNCT01479153
Venous Site for Central Catheterization
A study testing Randomization of the site for catheterization in people with Critical Care and Catheterization, run by University Hospital, Caen at 5 sites in France.
Trial summary
Central venous catheters are needed in the critical care setting to administer drugs. Three sites are available to gain vascular access: subclavian, internal jugular and femoral. Each site has complications, but there is no randomized controlled study which compared the 3 sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Catheterization, ICU
- What is being tested?
- Randomization of the site for catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,471 participants
- Where
- 5 sitesFrance
- Study dates
- Oct 2011to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient admitted in the Intensive Care Unit
- Requiring Central Venous Catheterization
Who cannot join
- Patients with only one site available
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Medical Intensive Care Unit, CHU Caen
Caen, 14000
Surgical Intensive Care Unit, CHU Caen
Caen, pottier-v@chu-caen.fr
Medical Intensive Care Unit, Cochin, AP-HP
Paris
Médical Intensive Care Unit, Lariboisière, AP-HP
Paris
Polyvalent Intensive Care Unit, Mémorial France Etats-Unis
Saint-Lô
About this study
Official title: Comparison of Subclavian, Femoral and Internal Jugular Venous Catheterization in Term of Complications in the Intensive Care Unit: a Randomized Controlled Trial
Central venous catheters are needed in the critical care setting to administer drugs. Three sites are available to gain vascular access: subclavian, internal jugular and femoral. Each site has complications, but there is no randomized controlled study which compared the 3 sites.
The investigators hypothesis is that subclavian catheterization reduces the risk of major complications compared to internal jugular or femoral.
- Conditions
- Critical Care, Catheterization, ICU
- Being tested
- Randomization of the site for catheterization
- Keywords
- Central venous catheterization, Major complications, Internal Jugular, Femoral, Subclavian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomization of the site for catheterizationProcedure or surgery
Ultra-sound guided insertion strongly recommended
| Study group | Role | What they receive |
|---|---|---|
| Subclavian catheterization | Active comparator | Not described Receives: Procedure: Randomization of the site for catheterization |
| Internal Jugular catheterization | Active comparator | Not described Receives: Procedure: Randomization of the site for catheterization |
| Femoral Catheterization | Active comparator | Not described Receives: Procedure: Randomization of the site for catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complications including catheter-related bloodstream infection
Catheter-related bloodstream infection: (positive catheter-tip quantitative culture plus positive peripheral blood culture(s))
Measured: From central catheter insertion to 48-h after removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2014
- Study completionFeb 2015
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 Critical CareStudies 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
- Outcomes assessor
- Enrolment
- 3,471 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Jacques Parienti, MD, PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479153
- Sponsor's protocol ID
- ID RCB 2010-A00813-36
- Acronym
- 3SITES
- Status last verified
- Jul 2015
- First submitted
- 22 Nov 2011
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.
PubMed 26398070Pages J, Hazera P, Megarbane B, du Cheyron D, Thuong M, Dutheil JJ, Valette X, Fournel F, Mermel LA, Mira JP, Daubin C, Parienti JJ; 3SITES Study Group. Comparison of alcoholic chlorhexidine and povidone-iodine cutaneous antiseptics for the prevention of central venous catheter-related infection: a cohort and quasi-experimental multicenter study. Intensive Care Med. 2016 Sep;42(9):1418-26. doi: 10.1007/s00134-016-4406-4. Epub 2016 Jun 16.
PubMed 27311311Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Valette X, Daubin C, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable model predicting the required catheter dwell time among mechanically ventilated critically ill patients in three randomized trials. Ann Intensive Care. 2023 Jan 16;13(1):5. doi: 10.1186/s13613-023-01099-9.
PubMed 36645531Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.
PubMed 35799302
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Subclavian, Femoral and Internal Jugular Venous Catheterization in Term of Complications in the Intensive Care Unit: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01479153
- Acronym / sponsor ID
- 3SITES / ID RCB 2010-A00813-36
- Conditions
- Critical Care, Catheterization, ICU
- Keywords
- Central venous catheterization, Major complications, Internal Jugular, Femoral, Subclavian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,471 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Nov 2011 (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.
Central venous catheters are needed in the critical care setting to administer drugs. Three sites are available to gain vascular access: subclavian, internal jugular and femoral. Each site has complications, but there is no randomized controlled study which compared the 3 sites.
The investigators hypothesis is that subclavian catheterization reduces the risk of major complications compared to internal jugular or femoral.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subclavian catheterization | Active comparator | Procedure: Randomization of the site for catheterization |
| Internal Jugular catheterization | Active comparator | Procedure: Randomization of the site for catheterization |
| Femoral Catheterization | Active comparator | Procedure: Randomization of the site for catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient admitted in the Intensive Care Unit
- Requiring Central Venous Catheterization
Key exclusion criteria (1 listed)
- Patients with only one site available
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 |
|---|---|---|
| Randomization of the site for catheterizationUltra-sound guided insertion strongly recommended | Procedure or surgery | Femoral Catheterization, Internal Jugular catheterization, Subclavian catheterization |
Primary outcome
Major complications including catheter-related bloodstream infection
Time frame: From central catheter insertion to 48-h after removal
Catheter-related bloodstream infection: (positive catheter-tip quantitative culture plus positive peripheral blood culture(s))
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 23 Aug 2016.
- Results publication: PubMed 26398070Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.
- Results publication: PubMed 27311311Pages J, Hazera P, Megarbane B, du Cheyron D, Thuong M, Dutheil JJ, Valette X, Fournel F, Mermel LA, Mira JP, Daubin C, Parienti JJ; 3SITES Study Group. Comparison of alcoholic chlorhexidine and povidone-iodine cutaneous antiseptics for the prevention of central venous catheter-related infection: a cohort and quasi-experimental multicenter study. Intensive Care Med. 2016 Sep;42(9):1418-26. doi: 10.1007/s00134-016-4406-4. Epub 2016 Jun 16.
- Derived from this study: PubMed 36645531Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Valette X, Daubin C, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable model predicting the required catheter dwell time among mechanically ventilated critically ill patients in three randomized trials. Ann Intensive Care. 2023 Jan 16;13(1):5. doi: 10.1186/s13613-023-01099-9.
- Derived from this study: PubMed 35799302Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.
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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.
Jean-Jacques Parienti, MD, PhD principal investigator
University Hospital, Caen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomization of the site for catheterization in people with Critical Care and Catheterization, run by University Hospital, Caen at 5 sites in France.
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 2 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 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Major complications including catheter-related bloodstream infection (time frame: From central catheter insertion to 48-h after removal). 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 NCT01479153, 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 23 Aug 2016.