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Pharmacological Management of Delirium

NCT00842608 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 551

Last updated 2018-08-17

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Reduced exposure to anticholinergics

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

PROCEDURE

Reduced exposure to benzodiazepines

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

DRUG

Haloperidol

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

PROCEDURE

Usual care

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Malaz Boustani, MD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00842608 on ClinicalTrials.gov