ARDS, HumanILCDVNCT03405038
Prone Position Impact in ARDS Patients on the Incidence of Central Venous Catheter Colonization
An observational study of ARDS, Human and Catheter Infection, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
Catheter colonization, catheter-associated infection and catheter-associated bacteremia are a major challenge for resuscitation unit. This study wishes to explore the impact of the central venous catheter colonization on the ARDS patient with and without prone position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human, Catheter Infection
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2017to 1 Jan 2019
- Phase
- Observational
- 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
Study population: ARDS patients with a central venous catheter placed or not into prone position
Who may be able to join
- Hospitalized patient in the reanimation unit of the CHR Metz-Thionville or the CHRU Nancy between january 2014 and december 2015
- Patient with an acute respiratory distress syndrome, moderate or severe
- With a central venous catheter
- With or without prone position during the stay
Who cannot join
- Minor patient
- Absence of information on central venous catheter bacteriology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prone Position Impact in Patients With Acute Respiratory Distress Syndrome on the Incidence of Central Venous Catheter Colonizations in Reanimation
Catheter colonization, catheter-associated infection and catheter-associated bacteremia are a major challenge for resuscitation unit. This study wishes to explore the impact of the central venous catheter colonization on the ARDS patient with and without prone position.
Read the detailed description
Catheter-associated infection prevention is achieved by identification of the population at risk. Patients receiving prone position Under acute respiratory distress syndrome appear to be particularly vulnerable. This retrospective study is designed to compare the risk of catheter colonization that could be induced or worsened by prone position. Knowing that, prone position is increased into the care acute respiratory distress syndrome since few years. Unfortunately, no study has examined the prone position impact on catheter-association infection in these population.
- Conditions
- ARDS, Human, Catheter Infection
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the prone position
Incidence rate of the bacterial colonization at least one catheter during the stay in resuscitation unit
Measured: Day 1
Secondary outcomes (1)
Infection associated factors
multivariate analysis of risks factor for the catheter colonization ((age, sex, comorbidity, weight, length of stay)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start2 Nov 2017
- Primary completion4 Jun 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405038
- Sponsor's protocol ID
- 2017-02-CHRMT
- Acronym
- ILCDV
- Status last verified
- Jan 2018
- First submitted
- 12 Jan 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Position Impact in Patients With Acute Respiratory Distress Syndrome on the Incidence of Central Venous Catheter Colonizations in Reanimation
- ClinicalTrials.gov ID
- NCT03405038
- Acronym / sponsor ID
- ILCDV / 2017-02-CHRMT
- Conditions
- ARDS, Human, Catheter Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 19 Jan 2018 (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.
Catheter colonization, catheter-associated infection and catheter-associated bacteremia are a major challenge for resuscitation unit. This study wishes to explore the impact of the central venous catheter colonization on the ARDS patient with and without prone position.
Detailed description
Catheter-associated infection prevention is achieved by identification of the population at risk. Patients receiving prone position Under acute respiratory distress syndrome appear to be particularly vulnerable. This retrospective study is designed to compare the risk of catheter colonization that could be induced or worsened by prone position. Knowing that, prone position is increased into the care acute respiratory distress syndrome since few years. Unfortunately, no study has examined the prone position impact on catheter-association infection in these population.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ARDS patients with a central venous catheter placed or not into prone position
Key inclusion criteria (4 listed)
- Hospitalized patient in the reanimation unit of the CHR Metz-Thionville or the CHRU Nancy between january 2014 and december 2015
- Patient with an acute respiratory distress syndrome, moderate or severe
- With a central venous catheter
- With or without prone position during the stay
Key exclusion criteria (2 listed)
- Minor patient
- Absence of information on central venous catheter bacteriology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of the prone position
Time frame: Day 1
Incidence rate of the bacterial colonization at least one catheter during the stay in resuscitation unit
1 secondary outcome
Infection associated factors
Time frame: Day 1
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 4 Feb 2019.
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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?
An observational study of ARDS, Human and Catheter Infection, run by Centre Hospitalier Régional Metz-Thionville 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 4 inclusion and 2 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 4 Feb 2019. 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?
Impact of the prone position (time frame: Day 1). 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 4 Feb 2019.