Patients requiring mechanical ventilation and sedation in ICU. MedDRA version: 8.0 Level: LLT Classification code 10039897
Conditions
Interventions
Product 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)/mil
Sponsors
Orion Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis and main criteria for inclusion and exclusion: Main criteria for inclusion: • Age ? 18 years • Clinical need for sedation and mechanical ventilation • Receiving full intensive care life support • Patients should have an expected stay in ICU for ? 48 hours from admission • Patients should have an expected requirement for sedation ? 24 hours from time of randomisation • Written informed consent obtained from the patient’s representative (and an independent physician where appropriate) within 36 hours of starting sedation, but not more than 72 h from the time of ICU admission 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: Main criteria for exclusion: • Acute severe neurological disorder due to vascular causes, infection, intracranial expansion or injury • Uncompensated acute circulatory failure at time of randomisation [severe hypotension with mean arterial pressure (MAP) 2, bilirybin>101 mcgmol/L • Positive pregnancy test or currently lactating • Need for muscle relaxation at the time of randomisation (except for intubation and initial stabilization) • Loss of hearing or vision, or any other condition that would significantly interfere with Richmond Agitation-Sedation Scale (RASS) assessment • Use of ?2-agonists or antagonists at the time of randomisation (see prior and concomitant treatments, Section 5.7)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objectives: Primary objective: The study has hierarchical co-primary objectives to demonstrate that: • Firstly: dexmedetomidine is non-inferior to current best-practice sedation with propofol/midazolam and daily sedation stops, in maintaining a target depth of sedation in long-stay (>24 hours sedation after randomisation) intensive care unit (ICU) patients • Secondly: use of dexmedetomidine, compared with current best-practice sedation with propofol/midazolam and daily sedation stops, reduces the length of ICU stay in long-stay (>24 hours sedation after randomisation) ICU patients. ;Secondary Objective: Secondary objectives: To explore the effects of dexmedetomidine compared with optimised standard care on: • nurse’s assessment of subject communication • duration of mechanical ventilation, weaning time and ventilator-free days in ICU • length of total hospital stay • functional recovery during hospitalisation • need for rescue medication to maintain sedation To describe the effects of dexmedetomidine compared with optimised standard care on: • frequency of delirium • frequency of organ failures and failure-free days • frequency of critical illness polyneuropathy (CIP) • ICU- and in-hospital survival To explore the potential differences between dexmedetomidine and optimised standard care in relation to: • costs of care in the ICU • total cost of hospitalisation To evaluate the range of blood levels seen with long-term treatment with dexmedetomidine ;Primary end point(s): Primary efficacy variables The hierarchical co-primary objectives of the study will be evaluated and analysed as follows: 1. Depth of sedation in long-stay (>24 hours sedation after randomisation) ICU patients The first of the co-primary efficacy variables is defined as the proportion of time during sedative infusion with a RASS score within the individually-prescribed target range. The comparison between the treatment groups will be done using analysis of (co-)variance [AN( | — |
Countries
Finland, United Kingdom
Outcome results
None listed