N/A
N=551
Pharmacological Management of Delirium
Delirium · Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT00842608 ↗Enrolled (actual)
551
Serious AEs
27.4%
Results posted
Mar 2017
Primary outcome: Primary: Days Free of Delirium and Coma — 4; 5; 4; 5 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reduced exposure to anticholinergics (Behavioral); Reduced exposure to benzodiazepines (Procedure); Haloperidol (Drug); Usual care (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days Free of Delirium and Coma |
4; 5; 4; 5 | — |
| SECONDARY Hospital Length of Stay Post Randomization |
20.2; 18.6; 18.8; 14.9 | — |
| SECONDARY Mortality |
20; 32; 11; 8 | — |
Summary
The purpose of this study is to develop and test the feasibility of using a specific pharmacological protocol to reduce delirium burden among older adults in the Intensive Care Unit (ICU). The study will test the efficacy of a pharmacological intervention in reducing delirium severity and duration as well as length of stay and mortality compared to usual care.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Hospitalized on an ICU ward
- Delirium based on the RASS and the CAM-ICU assessments at any day during ICU stay
- English speaking
Exclusion Criteria
- Admitted directly to a regular non-ICU ward
- Previously enrolled in the study
- Not eligible for delirium assessment as determined by RASS scores
- Prior history of severe mental illness
- Alcohol-related delirium
- Pregnant or nursing
- Have had an aphasic stroke
Data sourced from ClinicalTrials.gov (NCT00842608). 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.