NCT00842608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
551

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 24, 2017

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

6.4 years

First QC Date

February 10, 2009

Results QC Date

November 11, 2016

Last Update Submit

August 16, 2018

Conditions

DeliriumCognitive Impairment

Keywords

confusiondementia

Outcome Measures

Primary Outcomes (1)

  • Days Free of Delirium and Coma

    Admission through day 8 of stay

Secondary Outcomes (2)

  • 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

Study Arms (4)

Haloperidol Eligible Intervention

EXPERIMENTAL

0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines

Behavioral: Reduced exposure to anticholinergicsProcedure: Reduced exposure to benzodiazepinesDrug: Haloperidol

Haloperidol Eligible Usual Care

ACTIVE COMPARATOR

Usual care

Procedure: Usual care

Haldol-Ineligible Arm

EXPERIMENTAL

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

Behavioral: Reduced exposure to anticholinergicsProcedure: Reduced exposure to benzodiazepines

Haldol Ineligible Usual Care

ACTIVE COMPARATOR

Usual Care

Procedure: Usual care

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

Haldol-Ineligible ArmHaloperidol Eligible Intervention
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

Haldol-Ineligible ArmHaloperidol Eligible Intervention
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

Also known as: Haldol
Haloperidol Eligible Intervention
Usual carePROCEDURE

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

Haldol Ineligible Usual CareHaloperidol Eligible Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (5)

  • Wang S, Perkins AJ, Chi R, Yates BA, Khan SH, Gao S, Boustani M, Khan BA. Risk factors for dementia in older intensive care unit (ICU) survivors. Alzheimers Dement. 2024 Jan;20(1):278-287. doi: 10.1002/alz.13423. Epub 2023 Aug 17.

    PMID: 37589315DERIVED

  • Ortiz D, Lindroth HL, Braly T, Perkins AJ, Mohanty S, Meagher AD, Khan SH, Boustani MA, Khan BA. Delirium severity does not differ between medical and surgical intensive care units after adjusting for medication use. Sci Rep. 2022 Aug 24;12(1):14447. doi: 10.1038/s41598-022-18429-9.

    PMID: 36002562DERIVED

  • Lindroth H, Khan BA, Carpenter JS, Gao S, Perkins AJ, Khan SH, Wang S, Jones RN, Boustani MA. Delirium Severity Trajectories and Outcomes in ICU Patients. Defining a Dynamic Symptom Phenotype. Ann Am Thorac Soc. 2020 Sep;17(9):1094-1103. doi: 10.1513/AnnalsATS.201910-764OC.

    PMID: 32383964DERIVED

  • Khan BA, Perkins AJ, Campbell NL, Gao S, Farber MO, Wang S, Khan SH, Zarzaur BL, Boustani MA. Pharmacological Management of Delirium in the Intensive Care Unit: A Randomized Pragmatic Clinical Trial. J Am Geriatr Soc. 2019 May;67(5):1057-1065. doi: 10.1111/jgs.15781. Epub 2019 Jan 25.

    PMID: 30681720DERIVED

  • Campbell NL, Khan BA, Farber M, Campbell T, Perkins AJ, Hui SL, Abernathy G, Buckley J, Sing R, Tricker J, Zawahiri M, Boustani MA. Improving delirium care in the intensive care unit: the design of a pragmatic study. Trials. 2011 Jun 6;12:139. doi: 10.1186/1745-6215-12-139.

    PMID: 21645330DERIVED

MeSH Terms

Conditions

DeliriumCognitive DysfunctionConfusionDementia

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersCognition DisordersBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic Chemicals

Results Point of Contact

Title
Dr. Malaz Boustani
Organization
Regenstrief Institute, Inc.
mboustan@iu.edu
(317) 274-9235

Study Officials

  • Malaz Boustani, MD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 12, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 17, 2018

Results First Posted

March 24, 2017

Record last verified: 2018-08

Locations

US(3)