ObesityPhase 2CISEVOBNCT02042612
Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients
A Phase 2 study testing Sedation with sevoflurane during 48-hr in ICU in people with Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Sedation with sevoflurane during 48-hr in ICU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Feb 2015
- Phase
- Phase 2
- 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 BMI >30
Who cannot join
- Acute kidney injury BMI <30 Sevoflurane anaphylaxia
Trial locations and contacts
1 site in 1 country.
About this study
Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients
Read the detailed description
Prospective clinical monocentric study in ICU with sedated ventilated obese patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)
- Conditions
- Obesity
- Being tested
- Sedation with sevoflurane during 48-hr in ICU
- Keywords
- Pharmacokinetics, Sevoflurane, Obesity, Sedation, ICU patients
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation with sevoflurane during 48-hr in ICUDrug
Also called Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in obese ICU patients
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane | Experimental | Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in obese ICU patients Receives: Drug: Sedation with sevoflurane during 48-hr in ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of plasmatic concentrations of sevoflurane before using AnaConda® system
Measured: at 5min, 60 min, 24 hrs and just before the end of sedation.
Secondary outcomes (1)
Determination of plasmatic concentrations of HFIP and fluoride before using AnaConda® system
Measured: at 5min, 60 min, 24 hrs and just before the end of sedation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042612
- Sponsor's protocol ID
- CHU-0176
- Other IDs
- 2010-020044-35
- Acronym
- CISEVOB
- Status last verified
- Jun 2016
- First submitted
- 14 Jan 2014
- Last updated
- 27 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients
- ClinicalTrials.gov ID
- NCT02042612
- Acronym / sponsor ID
- CISEVOB / CHU-0176
- Conditions
- Obesity
- Keywords
- Pharmacokinetics, Sevoflurane, Obesity, Sedation, ICU patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 23 Jan 2014 (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.
Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients
Detailed description
Prospective clinical monocentric study in ICU with sedated ventilated obese patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sevoflurane | Experimental | Drug: Sedation with sevoflurane during 48-hr in ICUDetermination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in obese ICU patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line BMI >30
Key exclusion criteria (1 listed)
- Acute kidney injury BMI <30 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 |
|---|---|---|
| Sedation with sevoflurane during 48-hr in ICUAlso: Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in obese ICU patients | Drug | sevoflurane |
Primary outcome
Determination of plasmatic concentrations of sevoflurane before using AnaConda® system
Time frame: at 5min, 60 min, 24 hrs and just before the end of sedation.
1 secondary outcome
Determination of plasmatic concentrations of HFIP and fluoride before using AnaConda® system
Time frame: at 5min, 60 min, 24 hrs and just before the end of sedation.
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 27 Jun 2016.
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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.
Sébastien PERBET 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 Phase 2 study testing Sedation with sevoflurane during 48-hr in ICU in people with Obesity, 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 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 27 Jun 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 sevoflurane before using AnaConda® system (time frame: at 5min, 60 min, 24 hrs and just before the end of sedation.). 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 27 Jun 2016.