Clinical trial NCT01707680: Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients
Official title: Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Critical Illness
Keywords: weaning
mechanical ventilation
dexmedetomidine
propofol
midazolam
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2012-10-16
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult general intensive care patients Need of mechanical ventilation \>24 hours Need of light to moderate sedation

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion criteria:

* 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
* 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

Primary outcomes:
measure: The time point from when the patient is considered "fit for weaning" to the actual time point for extubation
timeFrame: 30 days
Secondary outcomes:
measure: Time-point for patient being considered "fit for extubation"
timeFrame: 30 days
measure: Total time in mechanical ventilation
timeFrame: 30 days
measure: Extubation failure (re-intubation within 24 hours)
timeFrame: 24 hours
measure: Anxiety/delirium assessments
timeFrame: 30 days
measure: Length of ICU stay (actual time of discharge)
timeFrame: 30 days
measure: QoL (15D)
timeFrame: 2-4 months post-ICU discharge
measure: Post-Traumatic Stress Disorder assessment - PTSS14 questionnaire
timeFrame: 2-4 months post-ICU discharge
measure: Total duration of sedation
timeFrame: 30 days
measure: Number of days using opioids
timeFrame: 30 days
measure: Number of days using antipsychotic/neuroleptic drugs
timeFrame: 30 days
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Danderyds Hospital Anestesi- och intensivvårdskliniken
city: Stockholm
country: Sweden
facility: Capio S:t Goran Hospital, Anestesikliniken
city: Örebro
country: Sweden
facility: Örebro University Hospital, Anestesi- och intensivvårdskliniken
Study officials:
affiliation: Danderyds Hospital, Danderyd, Sweden
name: Carl-Johan Wickerts, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.