CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 551 enrolled
Drug / intervention
Haloperidol +3 moredrug
Likely dose
Haloperidol 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00842608
NCT00842608N/ACompleted

Pharmacological Management of Delirium

Indiana University·interventional·Posted Feb 12, 2009·Updated Aug 17, 2018

In Brief

A clinical study evaluating Reduced exposure to anticholinergics, Reduced exposure to benzodiazepines, and 2 other interventions for Delirium and Cognitive Impairment. Completed, enrolled 551 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 12, 2009
Enrollment StartFeb 1, 2009
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 17.4 years ago

Interventions

Reduced exposure to anticholinergicsbehavioral

Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug. Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can \& cannot receive Haldol

Reduced exposure to benzodiazepinesprocedure

Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation

Haloperidoldrug

0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital

Usual careprocedure

May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium