Cardiac ArrestSEVOCARNCT02201134
SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia
A study testing sevoflurane in people with Cardiac Arrest and Therapeutic Hypothermia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic hypothermia of cardiac arrests resuscitated patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Arrest, Therapeutic Hypothermia
- What is being tested?
- sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Dec 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Adult patients ventilated requiring therapeutic hypothermia in ICU
- Stable respiratory and hemodynamic conditions
- Epinephrine and norepinephrine infusion rate < 1,5 g/kg/min
- Consent of patients or family
- Arterial line
- Patients resuscitated after cardiac arrest
Show all 12Show fewer
- No Flow < 10 min
- Low Flow < 20 min
- Neutropenia < 1 G/L
- Post traumatic cardiac arrest
- Contraindication of halogenated anesthesics
- Extra corporeal life support or intra aortic balloon pump
Who cannot join
- -Pregnant woman
- Hemodynamic instability
- Brain death defined by the disappearance of brain stem reflexes
Trial locations and contacts
1 site in 1 country.
About this study
Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic hypothermia of cardiac arrests resuscitated patients.
Read the detailed description
Prospective clinical study in ICU with ventilated patients sedated with sevoflurane using the Mirus® and Anaconda® , establishing the feasibility of an initial sedation of patients resuscitated from cardiac arrest and treated with therapeutic hypothermia.
- Conditions
- Cardiac Arrest, Therapeutic Hypothermia
- Being tested
- sevoflurane
- Keywords
- Cardiac arrest, Therapeutic hypothermia, Sevoflurane, Sedation, Patient resuscitated from cardiac arrest, Requiring sedation, Adult patients, Patient covered by french health care system
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane | Other | Not described Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the feasibility of a sedation with inhalated sevoflurane in cardiac arrest resuscitated patients
The feasibility is evaluated by the number of side effects due to treatment until discharge from hospital.
Measured: at day 1
Secondary outcomes (4)
Determination of neurological prognostic of patients at ICU and hospital discharge
Measured: at day 1
Determination of systemic complications and organ failures during hospitalisation
Measured: at day 1
Evaluation of systemic inflammation and evolution with cytokines
Measured: at day 1
Evaluation of markers specific of brain ischemia (S100 protein and neuron-specific enolase)
at 3 times: before starting sevoflurane sedation, 24 hours, 48 hours and 72 hours after starting sevoflurane sedation.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Estaing, Hopital Gabriel Montpied
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201134
- Sponsor's protocol ID
- CHU-0199
- Other IDs
- 2014-001196-31, 2014
- Acronym
- SEVOCAR
- Status last verified
- May 2021
- First submitted
- 16 Jul 2014
- Last updated
- 14 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia
- ClinicalTrials.gov ID
- NCT02201134
- Acronym / sponsor ID
- SEVOCAR / CHU-0199
- Conditions
- Cardiac Arrest, Therapeutic Hypothermia
- Keywords
- Cardiac arrest, Therapeutic hypothermia, Sevoflurane, Sedation, Patient resuscitated from cardiac arrest, Requiring sedation, Adult patients, Patient covered by french health care system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Estaing, Hopital Gabriel Montpied
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Jul 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.
Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic hypothermia of cardiac arrests resuscitated patients.
Detailed description
Prospective clinical study in ICU with ventilated patients sedated with sevoflurane using the Mirus® and Anaconda® , establishing the feasibility of an initial sedation of patients resuscitated from cardiac arrest and treated with therapeutic hypothermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sevoflurane | Other | Drug: sevoflurane |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -Adult patients ventilated requiring therapeutic hypothermia in ICU
- Stable respiratory and hemodynamic conditions
- Epinephrine and norepinephrine infusion rate < 1,5 g/kg/min
- Consent of patients or family
- Arterial line
Key exclusion criteria (3 listed)
- -Pregnant woman
- Hemodynamic instability
- Brain death defined by the disappearance of brain stem reflexes
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 | Drug | sevoflurane |
Primary outcome
Determination of the feasibility of a sedation with inhalated sevoflurane in cardiac arrest resuscitated patients
Time frame: at day 1
The feasibility is evaluated by the number of side effects due to treatment until discharge from hospital.
4 secondary outcomes
Determination of neurological prognostic of patients at ICU and hospital discharge
Time frame: at day 1
Determination of systemic complications and organ failures during hospitalisation
Time frame: at day 1
Evaluation of systemic inflammation and evolution with cytokines
Time frame: at day 1
Evaluation of markers specific of brain ischemia (S100 protein and neuron-specific enolase)
Time frame: at 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 14 Jul 2025.
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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 study testing sevoflurane in people with Cardiac Arrest and Therapeutic Hypothermia, 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 12 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 14 Jul 2025. 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 the feasibility of a sedation with inhalated sevoflurane in cardiac arrest resuscitated patients (time frame: at 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 14 Jul 2025.