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The study aims to demonstrate that 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 intensive care unit (ICU) patients, and that dexmedetomidine, compared with current best practice, reduces the length of ICU stay.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range | ||
| Time from ICU admission to discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Nurse's assessment of subject communication | ||
| Duration of mechanical ventilation, weaning time and ventilator-free days in ICU | ||
| Length of total hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jukka Takala, MD, PhD | University/University Hospital, Bern, Switzerland | Study Chair |
| Esko Ruokonen, MD, PhD | Kuopio University Hospital, Finland | Principal Investigator |
| Stephan Jakob, MD, PhD | University Hospital, Bern, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Finland | ||||
| Kuopio University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18795253 | Derived | Ruokonen E, Parviainen I, Jakob SM, Nunes S, Kaukonen M, Shepherd ST, Sarapohja T, Bratty JR, Takala J; "Dexmedetomidine for Continuous Sedation" Investigators. Dexmedetomidine versus propofol/midazolam for long-term sedation during mechanical ventilation. Intensive Care Med. 2009 Feb;35(2):282-90. doi: 10.1007/s00134-008-1296-0. Epub 2008 Sep 16. |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Functional recovery during hospitalisation |
| Need for rescue medication to maintain sedation |
| Frequency of delirium |
| Frequency of organ failures and failure-free days |
| Frequency of critical illness polyneuropathy |
| ICU- and in-hospital survival |
| Cost of care in the ICU |
| Total cost of hospitalisation |
| Blood levels of dexmedetomidine seen with long-term treatment |
| Kuopio |
| Finland |
| Tampere University Hospital | Tampere | Finland |
| Inselspital | Bern | Switzerland |