Phase 2
Completed N=53
Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium
Delirium · Agitation
Source: ClinicalTrials.gov NCT00351299 ↗
Enrolled (actual)
53
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Resolution of Delirium — 21; 14 Participants
Summary
The purpose of the research is to see if dexmedetomidine (a drug that has a calming effect - a sedative) is effective for the treatment of acute delirium
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resolution of Delirium |
21; 14 | — |
| SECONDARY Length of Ventilator Support |
1; 2 | — |
| SECONDARY Length of Intensive Care Unit (ICU) Stay |
7; 7.5 | — |
| SECONDARY Ease of Management for the Nursing Staff |
16; 7; 4; 2; 5; 19 | — |
| SECONDARY In-hospital Mortality |
1; 5; 24; 23 | — |
Eligibility Criteria
Inclusion Criteria
- Adults admitted to our surgical ICU who do not have any exclusion criteria
- Eligibility for treatment- Development of delirium as defined
Exclusion Criteria
- Acute MI (myocardial infarction),
- Trauma <24 hours,
- Head injury,
- Multiple organ failure,
- EF (ejection fraction) < 30%,
- History of hypersensitivity to alpha2 agonist,
- History of seizures, MAP (mean arterial pressure) <60 mm of Hg,
- Dysrhythmias a/with bradycardia (HR (heart rate) <50),
- Need for vasopressors,
- Acute renal failure with a need for dialysis/CVVH (Continuous Veno-Venous Hemofiltration) or liver disease.
- Women of child bearing age who do not have a documented negative pregnancy test and/or who do not actively use contraception. (Documented negative pregnancy test will be a urine pregnancy test obtained on this admission)
Data sourced from ClinicalTrials.gov (NCT00351299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.