SedationAnacondaNCT01196754
Pharmacokinetic of Sevoflurane During a 48h Sedation in Intensive Care Unit With AnaConDa®
A study testing sevoflurane in people with Sedation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This is a prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation
- What is being tested?
- sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to May 2009
- 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 ventilated more than 48 h
- Stable respiratory and hemodynamic conditions
- Consent of patients or family
- Arterial line
Who cannot join
- Acute kidney injury
- Obesity
- Sevoflurane anaphylaxia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic of Sevoflurane During a 48h Sedation in ICU With AnaConDa®
This is a prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane.
Read the detailed description
Prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)
- Conditions
- Sedation
- Being tested
- sevoflurane
- Keywords
- Pharmacokinetics, Sevoflurane, Fluorides, Sedation, Adult patients with a predicted sedation more than 48 h, Stable respiratory and hemodynamic conditions for SBT, Consent of patients, Arterial line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevofluraneOther
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane | Other | Not described Receives: Other: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of plasmatic concentrations of sévoflurane at different times of a 48h sedation of sévoflurane.
Measured: during 48 hours
Secondary outcomes (1)
Determination of plasmatic concentrations of HFIP and fluoride at different times of a 48h sedation of sévoflurane. Determination of a pharmacokinetic model of sévoflurane.
Measured: during 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startMar 2008
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Screening
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Estaing
- Investigators
- Daniel Bourdeaux, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196754
- Sponsor's protocol ID
- CHU-0079
- Acronym
- Anaconda
- Status last verified
- Sep 2010
- First submitted
- 15 Jul 2010
- Last updated
- 8 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic of Sevoflurane During a 48h Sedation in ICU With AnaConDa®
- ClinicalTrials.gov ID
- NCT01196754
- Acronym / sponsor ID
- Anaconda / CHU-0079
- Conditions
- Sedation
- Keywords
- Pharmacokinetics, Sevoflurane, Fluorides, Sedation, Adult patients with a predicted sedation more than 48 h, Stable respiratory and hemodynamic conditions for SBT, Consent of patients, Arterial line
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Estaing
- Study start
- Mar 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 8 Sep 2010 (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.
This is a prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane.
Detailed description
Prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)
Study design
- Primary purpose
- Screening
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sevoflurane | Other | Other: sevoflurane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients ventilated more than 48 h
- Stable respiratory and hemodynamic conditions
- Consent of patients or family
- Arterial line
Key exclusion criteria (3 listed)
- Acute kidney injury
- Obesity
- Sevoflurane anaphylaxia
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 |
|---|---|---|
| sevoflurane | Other | sevoflurane |
Primary outcome
Determination of plasmatic concentrations of sévoflurane at different times of a 48h sedation of sévoflurane.
Time frame: during 48 hours
1 secondary outcome
Determination of plasmatic concentrations of HFIP and fluoride at different times of a 48h sedation of sévoflurane. Determination of a pharmacokinetic model of sévoflurane.
Time frame: during 48 hours
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 8 Sep 2010.
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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.
Daniel Bourdeaux principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sevoflurane in people with Sedation, run by University Hospital, Clermont-Ferrand 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 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 8 Sep 2010. 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?
Determination of plasmatic concentrations of sévoflurane at different times of a 48h sedation of sévoflurane. (time frame: during 48 hours). 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 8 Sep 2010.