Dexmedetomidine Versus Midazolam for Continuous Sedation in the Intensive Care Unit (ICU) (MIDEX)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00481312 |
Recruitment Status
:
Completed
First Posted
: June 1, 2007
Last Update Posted
: May 7, 2012
|
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | May 31, 2007 | ||||||
First Posted Date ICMJE | June 1, 2007 | ||||||
Last Update Posted Date | May 7, 2012 | ||||||
Study Start Date ICMJE | June 2007 | ||||||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
|
||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT00481312 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Dexmedetomidine Versus Midazolam for Continuous Sedation in the Intensive Care Unit (ICU) | ||||||
Official Title ICMJE | A Prospective, Multi-centre, Randomised, Double-blind Comparison of Intravenous Dexmedetomidine With Midazolam for Continuous Sedation of Ventilated Patients in Intensive Care Unit | ||||||
Brief Summary | Patients in ICU who need help with their breathing are put onto a machine called a ventilator and are also given a medicine, called a sedative, which helps them to sleep and makes them more comfortable. Midazolam is a sedative that is routinely used for these purposes. For most patients the aim of sedation is to make them sleepy but still able to respond to nursing staff (light sedation) Dexmedetomidine is a new sedative for use in intensive care and in this clinical study, dexmedetomidine is compared to midazolam. It is thought that dexmedetomidine might be slightly better at allowing patients to be sleepy but still respond to people around them. It also does not appear to affect patient's breathing. the purpose of this study is to test whether dexmedetomidine really does have these advantages compared to midazolam. in this study we hope to show that: dexmedetomidine is at least as good as midazolam in helping patients to sleep better and making them more comfortable, and that they are able to co-operate better with the staff treating them, and that patients treated with dexmedetomidine require a shorter time on the ventilator than those treated with midazolam. |
||||||
Detailed Description | This is a phase III, multi-centre, prospective, randomised, double-blind, double-dummy, active comparator study. The study consists of three periods: screening, double-dummy treatment and follow-up period. All patients admitted to ICU will be pre-screened according to inclusion and exclusion criteria prior to informed consent using available clinical data. Informed consent, screening and randomisation procedures should be completed within 72 hours from the time of admission to ICU and within 48 hours from starting continuous sedation. Eligible study subjects requiring light to moderate sedation (Richmond Agitation-Sedation Scale [RASS] = 0 to -3) will be randomised to either continue on midazolam or switch to dexmedetomidine. Patients should not have received any other continuously or regularly administered sedative agent than midazolam infusion during the last 12 hours except for opioid analgesics. Study treatments will be titrated to achieve an individually targeted sedation range determined on a daily basis. Rescue treatment (i.e. propofol boli) may be given if needed to achieve the target depth of sedation. Continued need for sedation will be assessed at a daily sedation stop, conducted at the same time each day. First sedation stop may be 12-36 hours from randomisation, depending on the time of day the study subject is randomised. The duration of study treatment is limited to a maximum of 14 days from randomisation. Following withdrawal of sedation, study subjects will be monitored for 48 hours and contacted by telephone 31 and 45 days after randomisation. |
||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
||||||
Condition ICMJE | Continuous Sedation in Initially Sedated Adults in ICU | ||||||
Intervention ICMJE |
|
||||||
Study Arms |
|
||||||
Publications * |
|
||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
501 | ||||||
Original Estimated Enrollment ICMJE |
500 | ||||||
Actual Study Completion Date | October 2009 | ||||||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender |
|
||||||
Ages | 18 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Belgium, Estonia, Finland, France, Germany, Netherlands, Norway, Switzerland, United Kingdom | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00481312 | ||||||
Other Study ID Numbers ICMJE | 3005013 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Orion Corporation, Orion Pharma | ||||||
Study Sponsor ICMJE | Orion Corporation, Orion Pharma | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
|
||||||
PRS Account | Orion Corporation, Orion Pharma | ||||||
Verification Date | November 2009 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |