Patients requiring mechanical ventilation and sedation in ICU. MedDRA version: 8.0 Level: LLT Classification code 10039897
Conditions
Interventions
Trade Name: Precedex 100 microg/ml
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Dexmedetomidine
CAS Number: 145108-58-3
Concentration unit: µg/ml microgram(s)/milli
Sponsors
Orion Corporation Orion Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 years • Clinical need for sedation of an initially intubated (or tracheotomised) and ventilated (with inspiratory assistance) patient • Prescribed light to moderate sedation (target RASS = 0 to -3) using midazolam infusion • Patients should be randomised = 72 hours from ICU admission and = 48 hours of commencing continuous sedation in the ICU • Patients should have an expected requirement for sedation = 24 hours from time of randomisation • Written informed consent must be obtained according to local regulations before starting any study procedures other than pre-screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury • Uncompensated acute circulatory failure at time of randomisation (severe hypotension with MAP less than 55 mmHg despite volume and pressors) • Severe bradycardia (HR less than 50 beats/min) • AV-conduction block II-III (unless pacemaker installed) • Severe hepatic impairment (bilirubin more than 101 µmol/L) • Need for muscle relaxation at the time of randomisation (may only be used for intubation and initial stabilization) • Loss of hearing or vision, or any other condition which would significantly interfere with the collection of study data • Burn injuries and other injuries requiring regular anaesthesia or surgery • Use of centrally acting a2 agonists or antagonists (e.g. clonidine, titzanidine, apraclonidine and brimonidine) within 24 hours prior to randomisation • Known allergy to any of the study drugs or any excipients of the study drugs • Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis • Patients receiving sedation for therapeutic indications rather than to tolerate the ventilator (e.g. epilepsy) • Patients unlikely to require continuous sedation during mechanical ventilation (e.g. Guillain-Barre syndrome) • Patients who are unlikely to be weaned from mechanical ventilation; e.g. diseases/injuries primarily affecting the neuromuscular function of the respiratory apparatus such as clearly irreversible disease requiring prolonged ventilatory support (e.g. high spinal cord injury or advanced amyotrophic lateral sclerosis) • Distal paraplegia • Positive pregnancy test or currently lactating • Received any investigational drug within the preceding 30 days • Concurrent participation in any other interventional study (any study in which patients are allocated to different treatment groups and/or non-routine diagnostic or monitoring procedures are performed) • Previous participation in this study • Any other condition which, in the investigator’s opinion, would make it detrimental for the subject to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study has hierarchical co-primary objectives to demonstrate that: • Firstly: dexmedetomidine is at least as effective as sedation with midazolam and daily sedation stops, in maintaining a target depth of sedation in ventilated patients in intensive care unit (ICU) • Secondly: use of dexmedetomidine, compared with sedation with midazolam and daily sedation stops, reduces the duration of mechanical ventilation in ventilated patients in ICU ;Secondary Objective: The secondary objectives of this study are: • To show that dexmedetomidine improves rousability, communication of pain and cooperation compared with midazolam using nurse’s assessment of subject communication • To show that dexmedetomidine shortens length of ICU stay compared with midazolam • To evaluate the safety of dexmedetomidine compared to midazolam ;Primary end point(s): Primary efficacy variables: • Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required. RASS score will be assessed approximately 2 hourly during the treatment period and during the 48-hour follow-up period. In addition, RASS score should be assessed each time rescue treatment is given to maintain the target sedation level. • Duration of mechanical ventilation | — |
Countries
Belgium, Estonia, Finland, France, Germany, Netherlands, United Kingdom
Outcome results
None listed