Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
EUCTR |
Last refreshed on:
|
19 March 2012 |
Main ID: |
EUCTR2006-006031-50-FI |
Date of registration:
|
27/03/2007 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH MIDAZOLAM FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT - Midex
|
Scientific title:
|
A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH MIDAZOLAM FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT - Midex |
Date of first enrolment:
|
24/04/2007 |
Target sample size:
|
500 |
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006031-50 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
|
Phase:
|
|
|
Countries of recruitment
|
Belgium
|
Estonia
|
Finland
|
France
|
Germany
|
Netherlands
|
United Kingdom
| |
Contacts
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
| |
Key inclusion & exclusion 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: • 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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
Patients requiring mechanical ventilation and sedation in ICU. MedDRA version: 8.0
Level: LLT
Classification code 10039897
|
Intervention(s)
|
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)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use
Trade Name: MIDAZOLAM HAMELN 1 mg/ml solution for injection Pharmaceutical Form: Injection* INN or Proposed INN: Midazolam CAS Number: 59467-70-8 Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 1- Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intravenous use
|
Primary Outcome(s)
|
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
|
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
|
Source(s) of Monetary Support
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|