Pharmacological Management of Delirium

Not Applicable

Completed

Conditions: Delirium
Cognitive Impairment

Interventions: Procedure: Usual care
Behavioral: Reduced exposure to anticholinergics
Procedure: Reduced exposure to benzodiazepines
Drug: Haloperidol

Registration Number: NCT00842608

Lead Sponsor: Indiana University

Brief 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.

Detailed Description: In 2005, approximately 2.7 million Americans aged 65 and older spent at least one day in the intensive care unit (ICU), costing Medicare an estimated $27.5 billion. It is estimated that while hospitalized, up to 80% of these older ICU patients had delirium, an acute brain failure that is an independent predictor of morbidity and mortality which often goes unrecognized. Older adults with delirium are more prone to falls, injuries, pressure ulcers and restraints, complications which may also contribute to prolonged ICU and hospital length of stay, higher mortality rates, poorer functional status, limited rehabilitation, increased institutionalization, and higher health care costs. The literature supports treatment with a combination of a reduction in the use of benzodiazepines and anticholinergics and the use of low-dose neuroleptics such as haloperidol. However, there have been no randomized controlled trials evaluating the efficacy of this approach on reducing delirium severity, duration, and complications.

Building upon the e-CHAMP study, ("Enhancing Care for Hospitalized Older Adults With Memory Problems;" see NCT00182832), a recently completed quality improvement project tested the effectiveness of cognitive screening coupled with computerized decision support in reducing delirium and other hospital-related complications among 424 older adults hospitalized on the medical wards, which found that many of the older adults entering the study had already experienced delirium in the ICU prior to their transfer to the wards. This study will test a pharmacologic intervention that allows a more targeted approach to the care of older adults with delirium while still recognizing the clinicians' role in controlling symptoms and providing intensive care.

The hypothesis is that patients in the intervention arm as compared to usual care will have:

* reduced delirium severity, as measured by the Delirium Rating Scale (DRS-R-98), at one week following randomization or hospital discharge

* fewer hospital days with delirium or coma as determined by the Confusion Assessment Method in the ICU (CAM-ICU)

* shorter hospital lengths of stay

* lower ICU, hospital, and 30-day mortality

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 551

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Haloperidol Eligible Usual Care	Usual care	Usual care
Haloperidol Eligible Intervention	Reduced exposure to benzodiazepines	0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Haldol-Ineligible Arm	Reduced exposure to benzodiazepines	Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures. Patients are randomized and will still receive: reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Haloperidol Eligible Intervention	Reduced exposure to anticholinergics	0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Haloperidol Eligible Intervention	Haloperidol	0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Haldol-Ineligible Arm	Reduced exposure to anticholinergics	Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures. Patients are randomized and will still receive: reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Haldol Ineligible Usual Care	Usual care	Usual Care

Primary Outcome Measures

Name	Time	Method
Days Free of Delirium and Coma	Admission through day 8 of stay

Secondary Outcome Measures

Name	Time	Method
Hospital Length of Stay Post Randomization	Participants were followed for the duration of hospital stay, an average of 11 days
Mortality	ICU, in-hospital, 30-days post hospitalization

Trial Locations

Locations (3): Eskenazi Hospital
🇺🇸
Indianapolis, Indiana, United States
Methodist Hospital
🇺🇸
Indianapolis, Indiana, United States
University Hospital
🇺🇸
Indianapolis, Indiana, United States