Patients requiring mechanical ventilation and sedation in the ICU MedDRA version: 14.1 Level: PT Classification code 10039897 Term: Sedation System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Dexmedetomidine
Product Code: NA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DEXMEDETOMIDINE
CAS Number: 113775-47-6
Concentration unit: µg/ml microgr
Sponsors
ORION CORPORATION ORION PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Written informed consent obtained from the patient. •18 years or older. •Patients who have failed one weaning trial. •Receiving propofol as a sole agent for continuous sedation (minimum 12 hours) with target sedation level Richmond Agitation-Sedation Scale (RASS) +1 to -2 (must be in target at randomisation). •Intubated and mechanically ventilated in the ICU for more than 24 hours. •Patient has nasogastric (NG)/feeding tube in-situ. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: •Patients who have failed more than one weaning trial. •Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury. •Uncompensated acute circulatory failure at the time of randomisation (severe hypotension with mean arterial pressure less than 55 mmHg despite volume and vasopressors). •Severe bradycardia (heart rate [HR] less than 50 bpm). •AV conduction block II-III (unless pacemaker installed). •Unstable angina or acute myocardial infarction. •Severe hepatic impairment (bilirubin more than 101 ?mol/l). •Need for muscle relaxation at the time of randomisation (could only be used for intubation and initial stabilisation). •Acute renal failure requiring dialytic treatment of all types. •Pregnancy or breastfeeding. •Patients with tracheostomy. •Use of centrally acting alpha-2 agonists or antagonists (e.g. clonidine, titzanidine, apraclonidine and brimonidine) within 24 hours prior to randomisation. •Patients expected to have treatment withdrawn or withheld due to poor prognosis. •Patients 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 amyotrophic lateral sclerosis). •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, could make it detrimental for the patient to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate effects of dexmedetomidine on diaphragmatic neural activity (EAdi) over 24 hours after starting study treatment in difficult to wean mechanically ventilated patients.;Secondary Objective: • to investigate effects of dexmedetomidine on other aspects of patient/ventilator interaction and respiratory pattern over 24 hours after starting study treatment; • to describe effects of dexmedetomidine on time to extubation, duration of mechanical ventilation and depth of sedation during the study; • to evaluate the safety of dexmedetomidine during the study.;Primary end point(s): Asynchrony index (AI), defined as the total number of asynchronies as a proportion of the total number of respiratory efforts.;Timepoint(s) of evaluation of this end point: 0.5, 1, 2, 6, 12, 18 and 24 hours after starting study treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Other neural parameters; - Respiratory parameters; - Aterial blood gases; - Time to extubation; - Duration of mechanical ventilation; - Sedation variables; - Use of opioids; - Duration of ICU stay;Timepoint(s) of evaluation of this end point: 0.5, 1, 2, 6, 12, 18 and 24 hours after randomisation or as appropriate | — |
Countries
Italy
Contacts
Public ContactClinical Trials Information Desk
Orion Corporation
Outcome results
None listed