Respiratory InsufficiencyNCT00122707
Comparison of Central and Peripheral Venous Catheters
A study testing catheters in people with Respiratory Insufficiency and Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to compare the mechanical and infectious complications of peripheral versus central venous catheters in critically ill patients. Group allocation will be performed by randomization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Shock, Coma
- What is being tested?
- catheters
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2004to Oct 2005
- 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
- Patients requiring low to moderate doses of continuous catecholamine administration in the ICU
- Patients with 2 failed attempts at inserting a peripheral line
- Patients who require daily change of lines
Who cannot join
- Patients aged less than 18 years
- Pregnancy
- Absolute necessity of central venous access (refractory shock/high dose catecholamine infusion)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Mechanical and Infectious Complications of Central Versus Peripheral Venous Catheters in ICU Patients
The purpose of this study is to compare the mechanical and infectious complications of peripheral versus central venous catheters in critically ill patients. Group allocation will be performed by randomization.
Read the detailed description
Critically ill patients require intravenous administration of fluids and drugs. This can be achieved via peripheral or central catheters. Each device is associated with both mechanical and infectious complications. Complications associated with central lines are judged to be more severe. Some patients actually require the insertion of a central line due to the venous toxicity of the drugs or to the necessity of making sure that the infusion is regularly administered (example: high dose catecholamine infusion). Some physicians believe that most Intensive Care Unit (ICU) patients should have a central venous line inserted, whereas others feel that some patients may receive active drugs via a peripheral line in selected instances. No study prospectively compared the feasibility, merits and complications of the two possibilities (i.e., central or peripheral venous line). This study includes patients that can receive either a central or a peripheral line (see inclusion criteria): mainly patients receiving large amounts of fluid, moderate doses of catecholamines or of drugs that may cause venous injury. Patients are randomized to receive either a peripheral or a central venous catheter. Endpoints are the rate of mechanical complications (difficulty in inserting the line, need for repeat insertion attempts, occurrence of arterial puncture, occurrence of pneumothorax) and of infectious complications (local catheter infection or catheter-related bloodstream infection).
- Conditions
- Respiratory Insufficiency, Shock, Coma
- Being tested
- catheters
- Keywords
- catheter-related infection, mechanical complications of catheters
- Medical subject headings
- Respiratory Insufficiency, Shock, Coma, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cathetersDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
failure to insert line
mechanical complications of intravenous line insertion
infectious complications of intravenous lines
Secondary outcomes (1)
number of cross-overs (due to impossibility of inserting/maintaining a peripheral line)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startApr 2004
- Study completionOct 2005
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 Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Damien Ricard, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122707
- Sponsor's protocol ID
- LMR1
- Status last verified
- Jun 2005
- First submitted
- 19 Jul 2005
- Last updated
- 22 Mar 2006
- Results posted
- No
Publications
Timsit JF. [Updating of the 12th consensus conference of the Societe de Reanimation de langue francaise (SRLF): catheter related infections in the intensive care unit]. Ann Fr Anesth Reanim. 2005 Mar;24(3):315-22. doi: 10.1016/j.annfar.2004.12.022. French.
PubMed 15792575Polderman KH, Girbes AJ. Central venous catheter use. Part 1: mechanical complications. Intensive Care Med. 2002 Jan;28(1):1-17. doi: 10.1007/s00134-001-1154-9. Epub 2001 Dec 4.
PubMed 11818994Polderman KH, Girbes AR. Central venous catheter use. Part 2: infectious complications. Intensive Care Med. 2002 Jan;28(1):18-28. doi: 10.1007/s00134-001-1156-7. Epub 2001 Nov 29.
PubMed 11818995Ricard JD, Salomon L, Boyer A, Thiery G, Meybeck A, Roy C, Pasquet B, Le Miere E, Dreyfuss D. Central or peripheral catheters for initial venous access of ICU patients: a randomized controlled trial. Crit Care Med. 2013 Sep;41(9):2108-15. doi: 10.1097/CCM.0b013e31828a42c5.
PubMed 23782969
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Mechanical and Infectious Complications of Central Versus Peripheral Venous Catheters in ICU Patients
- ClinicalTrials.gov ID
- NCT00122707
- Acronym / sponsor ID
- LMR1
- Conditions
- Respiratory Insufficiency, Shock, Coma
- Keywords
- catheter-related infection, mechanical complications of catheters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Oct 2005
- First posted
- 22 Jul 2005 (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.
The purpose of this study is to compare the mechanical and infectious complications of peripheral versus central venous catheters in critically ill patients. Group allocation will be performed by randomization.
Detailed description
Critically ill patients require intravenous administration of fluids and drugs. This can be achieved via peripheral or central catheters. Each device is associated with both mechanical and infectious complications. Complications associated with central lines are judged to be more severe. Some patients actually require the insertion of a central line due to the venous toxicity of the drugs or to the necessity of making sure that the infusion is regularly administered (example: high dose catecholamine infusion). Some physicians believe that most Intensive Care Unit (ICU) patients should have a central venous line inserted, whereas others feel that some patients may receive active drugs via a peripheral line in selected instances. No study prospectively compared the feasibility, merits and complications of the two possibilities (i.e., central or peripheral venous line). This study includes patients that can receive either a central or a peripheral line (see inclusion criteria): mainly patients receiving large amounts of fluid, moderate doses of catecholamines or of drugs that may cause venous injury. Patients are randomized to receive either a peripheral or a central venous catheter. Endpoints are the rate of mechanical complications (difficulty in inserting the line, need for repeat insertion attempts, occurrence of arterial puncture, occurrence of pneumothorax) and of infectious complications (local catheter infection or catheter-related bloodstream infection).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring low to moderate doses of continuous catecholamine administration in the ICU
- Patients with 2 failed attempts at inserting a peripheral line
- Patients who require daily change of lines
Key exclusion criteria (3 listed)
- Patients aged less than 18 years
- Pregnancy
- Absolute necessity of central venous access (refractory shock/high dose catecholamine infusion)
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 |
|---|---|---|
| catheters | Device | – |
Primary outcome
failure to insert line
mechanical complications of intravenous line insertion
infectious complications of intravenous lines
1 secondary outcome
number of cross-overs (due to impossibility of inserting/maintaining a peripheral line)
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 22 Mar 2006.
- Background: PubMed 15792575Timsit JF. [Updating of the 12th consensus conference of the Societe de Reanimation de langue francaise (SRLF): catheter related infections in the intensive care unit]. Ann Fr Anesth Reanim. 2005 Mar;24(3):315-22. doi: 10.1016/j.annfar.2004.12.022. French.
- Background: PubMed 11818994Polderman KH, Girbes AJ. Central venous catheter use. Part 1: mechanical complications. Intensive Care Med. 2002 Jan;28(1):1-17. doi: 10.1007/s00134-001-1154-9. Epub 2001 Dec 4.
- Background: PubMed 11818995Polderman KH, Girbes AR. Central venous catheter use. Part 2: infectious complications. Intensive Care Med. 2002 Jan;28(1):18-28. doi: 10.1007/s00134-001-1156-7. Epub 2001 Nov 29.
- Derived from this study: PubMed 23782969Ricard JD, Salomon L, Boyer A, Thiery G, Meybeck A, Roy C, Pasquet B, Le Miere E, Dreyfuss D. Central or peripheral catheters for initial venous access of ICU patients: a randomized controlled trial. Crit Care Med. 2013 Sep;41(9):2108-15. doi: 10.1097/CCM.0b013e31828a42c5.
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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-Damien Ricard, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catheters in people with Respiratory Insufficiency and Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 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 22 Mar 2006. 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 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?
failure to insert line. The study lists 3 primary outcomes in all. 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 NCT00122707, 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 22 Mar 2006.