Sedation for Mechanical VentilationPhase 4KetaReaNCT01560390
Use of Ketamine Associate With an Opioid for Sedation in ICU
A Phase 4 study testing Rémifentamil + KETAMINE and ketamine in people with Sedation for Mechanical Ventilation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of the study is to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation for Mechanical Ventilation
- What is being tested?
- Rémifentamil + KETAMINE and ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Aug 2012
- Phase
- Phase 4
- 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
- all patients under mechanical ventilation
Who cannot join
- pregnant
- psychotic
- chronic use of opiates
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Ketamine Associate With an Opioid for Sedation in ICU : a Randomized Controlled Double Blind Study
The aim of the study is to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
Read the detailed description
All consecutive mechanically ventilated patients admitted in the intensive care unit (ICU)will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician.
- Conditions
- Sedation for Mechanical Ventilation
- Being tested
- Rémifentamil + KETAMINE, ketamine
- Keywords
- Sedation, ICU, Ketamine, Confusion, Hyperalgesia
- Medical subject headings
- Confusion, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rémifentamil + KETAMINEDrug
All consecutive mechanically ventilated patients admitted in the ICU will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician.
ketamineDrug
to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
| Study group | Role | What they receive |
|---|---|---|
| Rémifentanil + Kétamine | Other | to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine. Receives: Drug: Rémifentamil + KETAMINE; Drug: ketamine |
| Rémifentanil + Placebo | Other | to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine. Receives: Drug: Rémifentamil + KETAMINE; Drug: ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of opiate used between study enrollment and mechanical ventilation withdrawal.
Measured: after 24 hours
Secondary outcomes (5)
Confusion Duration assessed by CAM-ICU
Measured: after 24 hours
mechanical ventilation duration
Measured: after 24 hours
ICU length of stay
Measured: after 24 hours
Mortality at D28
Measured: at day 28
hyperalgesia during sedation
Measured: after 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation for Mechanical VentilationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel CONSTANTIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560390
- Sponsor's protocol ID
- CHU-0108
- Acronym
- KetaRea
- Status last verified
- Jan 2013
- First submitted
- 17 Nov 2011
- Last updated
- 14 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ketamine Associate With an Opioid for Sedation in ICU : a Randomized Controlled Double Blind Study
- ClinicalTrials.gov ID
- NCT01560390
- Acronym / sponsor ID
- KetaRea / CHU-0108
- Conditions
- Sedation for Mechanical Ventilation
- Keywords
- Sedation, ICU, Ketamine, Confusion, Hyperalgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Mar 2012 (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 aim of the study is to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
Detailed description
All consecutive mechanically ventilated patients admitted in the intensive care unit (ICU)will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rémifentanil + Kétamine | Other | Drug: Rémifentamil + KETAMINE, Drug: ketamineto evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine. |
| Rémifentanil + Placebo | Other | Drug: Rémifentamil + KETAMINE, Drug: ketamineto evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients under mechanical ventilation
Key exclusion criteria (4 listed)
- pregnant
- psychotic
- chronic use of opiates
- age < 18 years
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 |
|---|---|---|
| Rémifentamil + KETAMINEAll consecutive mechanically ventilated patients admitted in the ICU will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician. | Drug | Rémifentanil + Kétamine, Rémifentanil + Placebo |
| ketamineto evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine. | Drug | Rémifentanil + Kétamine, Rémifentanil + Placebo |
Primary outcome
Amount of opiate used between study enrollment and mechanical ventilation withdrawal.
Time frame: after 24 hours
5 secondary outcomes
Confusion Duration assessed by CAM-ICU
Time frame: after 24 hours
mechanical ventilation duration
Time frame: after 24 hours
ICU length of stay
Time frame: after 24 hours
Mortality at D28
Time frame: at day 28
hyperalgesia during sedation
Time frame: after 24 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 14 Jan 2013.
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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-Michel CONSTANTIN 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 4 study testing Rémifentamil + KETAMINE and ketamine in people with Sedation for Mechanical Ventilation, 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 4 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 Jan 2013. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Amount of opiate used between study enrollment and mechanical ventilation withdrawal. (time frame: after 24 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 14 Jan 2013.