Critical IllnessNICEWEANNCT01707680
Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients
An observational study of Critical Illness, run by Orion Corporation, Orion Pharma at 3 sites in Sweden.
Trial summary
The purpose of this study is to determine whether the use of different sedatives affect the weaning process from mechanical ventilation in intensive care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- SOC
- How many people
- 155 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Jun 2012to 1 Nov 2015
- 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: Adult general intensive care patients Need of mechanical ventilation >24 hours Need of light to moderate sedation
Who may be able to join
- Admitted to a general ICU ward
- ≥ 18years
- Intubated and mechanically ventilated for at least 24 hours
- Need of light to moderate sedation (corresponding to RASS 0 - (-3) or MAAS 2-3)
- Sedated with dexmedetomidine, midazolam and/or propofol
- Good knowledge in Swedish language
- Signed informed consent
Who cannot join
- Lack of fulfilling prescribed sedation regime
- Estimated high risk of death during the study period, according to investigator (roughly equal to estimated mortality rate (EMR) > 80% )
- Tracheotomy
- Change in sedative drugs since the "fit for weaning" time point
- Use of other alpha-2 agonists (clonidine) during ICU stay
- Positive pregnancy test or currently lactating/ known pregnancy or lactation
Show all 9Show fewer
- Participation in other study involving use of a pharmacologically active compound
- Patients with limitations in therapy
- Otherwise unable to fulfill the study, according to investigator's opinion
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Danderyds Hospital Anestesi- och intensivvårdskliniken
Danderyd, SE18288
Örebro University Hospital, Anestesi- och intensivvårdskliniken
Örebro, SE70185
Capio S:t Goran Hospital, Anestesikliniken
Stockholm, SE11281
About this study
The purpose of this study is to determine whether the use of different sedatives affect the weaning process from mechanical ventilation in intensive care patients.
Read the detailed description
Traditionally patients with ongoing mechanical ventilation have been sedated to assure absence of pain, anxiety and to provide comfort. Unfortunately this approach might have negative consequences such as prolonged time for mechanical ventilation, length of stay in the ICU and hospital.
In this study, the investigators would like to investigate (in an exploratory way due to the non-interventional setup) whether weaning from mechanical ventilation will be affected by the choice of sedatives - including dexmedetomidine, midazolam and propofol. This study also aims at investigating how the choice of primary sedative will affect delirium/anxiety, need of other medications (sedatives, analgesics, anti-psychotics), quality of life after ICU and the presence of Post-Traumatic Stress Disorder. In addition, the investigators aim at receiving information from the caregivers on their ICU experience, as recent data imply that not only the ICU patient but also the caregiver suffer from PTSD after the ICU stay.
- Conditions
- Critical Illness
- Being tested
- SOC
- Keywords
- weaning, mechanical ventilation, dexmedetomidine, propofol, midazolam
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOCOther
Patient are given standard of care
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Here, patients to be included are those being sedated with dexmedetomidine as primary sedative. Receives: Other: SOC | |
| Propofol | Here, patients to be included are those being sedated with propofol as primary sedative. Receives: Other: SOC | |
| Midazolam | Here, patients to be included are those being sedated with midazolam as primary sedative Receives: Other: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time point from when the patient is considered "fit for weaning" to the actual time point for extubation
Measured: 30 days
Secondary outcomes (10)
Time-point for patient being considered "fit for extubation"
Measured: 30 days
Total time in mechanical ventilation
Measured: 30 days
Extubation failure (re-intubation within 24 hours)
Measured: 24 hours
Anxiety/delirium assessments
RASS/MAAS sedation scales and ICDSC/CAM-ICU delirium assessments methods are used, as appropriate
Measured: 30 days
Length of ICU stay (actual time of discharge)
Measured: 30 days
QoL (15D)
Measured: 2-4 months post-ICU discharge
Post-Traumatic Stress Disorder assessment - PTSS14 questionnaire
This assessment will be offered to the ICU patients but also to their caregivers.
Measured: 2-4 months post-ICU discharge
Total duration of sedation
Measured: 30 days
Number of days using opioids
Measured: 30 days
Number of days using antipsychotic/neuroleptic drugs
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study start1 Jun 2012
- Primary completion1 Nov 2015
- Study completion1 Nov 2015
Why it stopped: Halted due to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl-Johan Wickerts, MD, Principal investigator, Danderyds Hospital, Danderyd, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707680
- Sponsor's protocol ID
- 3005022
- Other IDs
- Dnr 2012/628-31/4
- Acronym
- NICEWEAN
- Status last verified
- Sep 2019
- First submitted
- 12 Oct 2012
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nunes SL, Forsberg S, Blomqvist H, Berggren L, Sorberg M, Sarapohja T, Wickerts CJ. Effect of Sedation Regimen on Weaning from Mechanical Ventilation in the Intensive Care Unit. Clin Drug Investig. 2018 Jun;38(6):535-543. doi: 10.1007/s40261-018-0636-2.
PubMed 29502195
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT01707680
- Acronym / sponsor ID
- NICEWEAN / 3005022
- Conditions
- Critical Illness
- Keywords
- weaning, mechanical ventilation, dexmedetomidine, propofol, midazolam
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Halted due to slow recruitment
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 1 Nov 2015 (actual)
- Study completion
- 1 Nov 2015 (actual)
- First posted
- 16 Oct 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 purpose of this study is to determine whether the use of different sedatives affect the weaning process from mechanical ventilation in intensive care patients.
Detailed description
Traditionally patients with ongoing mechanical ventilation have been sedated to assure absence of pain, anxiety and to provide comfort. Unfortunately this approach might have negative consequences such as prolonged time for mechanical ventilation, length of stay in the ICU and hospital.
In this study, the investigators would like to investigate (in an exploratory way due to the non-interventional setup) whether weaning from mechanical ventilation will be affected by the choice of sedatives - including dexmedetomidine, midazolam and propofol. This study also aims at investigating how the choice of primary sedative will affect delirium/anxiety, need of other medications (sedatives, analgesics, anti-psychotics), quality of life after ICU and the presence of Post-Traumatic Stress Disorder. In addition, the investigators aim at receiving information from the caregivers on their ICU experience, as recent data imply that not only the ICU patient but also the caregiver suffer from PTSD after the ICU stay.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | – | Other: SOCHere, patients to be included are those being sedated with dexmedetomidine as primary sedative. |
| Propofol | – | Other: SOCHere, patients to be included are those being sedated with propofol as primary sedative. |
| Midazolam | – | Other: SOCHere, patients to be included are those being sedated with midazolam as primary sedative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult general intensive care patients Need of mechanical ventilation >24 hours Need of light to moderate sedation
Key inclusion criteria (7 listed)
- Admitted to a general ICU ward
- ≥ 18years
- Intubated and mechanically ventilated for at least 24 hours
- Need of light to moderate sedation (corresponding to RASS 0 - (-3) or MAAS 2-3)
- Sedated with dexmedetomidine, midazolam and/or propofol
Key exclusion criteria (9 listed)
- Lack of fulfilling prescribed sedation regime
- Estimated high risk of death during the study period, according to investigator (roughly equal to estimated mortality rate (EMR) > 80% )
- Tracheotomy
- Change in sedative drugs since the "fit for weaning" time point
- Use of other alpha-2 agonists (clonidine) during ICU stay
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 |
|---|---|---|
| SOCPatient are given standard of care | Other | Dexmedetomidine, Midazolam, Propofol |
Primary outcome
The time point from when the patient is considered "fit for weaning" to the actual time point for extubation
Time frame: 30 days
10 secondary outcomes
Time-point for patient being considered "fit for extubation"
Time frame: 30 days
Total time in mechanical ventilation
Time frame: 30 days
Extubation failure (re-intubation within 24 hours)
Time frame: 24 hours
Anxiety/delirium assessments
Time frame: 30 days
Length of ICU stay (actual time of discharge)
Time frame: 30 days
QoL (15D)
Time frame: 2-4 months post-ICU discharge
Post-Traumatic Stress Disorder assessment - PTSS14 questionnaire
Time frame: 2-4 months post-ICU discharge
Total duration of sedation
Time frame: 30 days
Number of days using opioids
Time frame: 30 days
Number of days using antipsychotic/neuroleptic drugs
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Halted due to slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Results publication: PubMed 29502195Nunes SL, Forsberg S, Blomqvist H, Berggren L, Sorberg M, Sarapohja T, Wickerts CJ. Effect of Sedation Regimen on Weaning from Mechanical Ventilation in the Intensive Care Unit. Clin Drug Investig. 2018 Jun;38(6):535-543. doi: 10.1007/s40261-018-0636-2.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
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.
Carl-Johan Wickerts, MD principal investigator
Danderyds Hospital, Danderyd, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Orion Corporation, Orion Pharma at 3 sites in Sweden.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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 was stopped early (reason given: Halted due to slow recruitment). Results are not available in the source record.
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?
The time point from when the patient is considered "fit for weaning" to the actual time point for extubation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01707680, which also lists 1 linked publication.
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 6 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.