Pilot Study of Haloperidol to Treat Critical Illness Delirium

NCT00429676 | Completed Phase 2

• 1 other identifier: 05-0362
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine whether haloperidol reduces the time on the breathing machine in critically ill patients with delirium.

Conditions

Delirium; Critical Illness

Keywords

Randomized; Controlled; Trial; Delirium; Haloperidol

Outcome Measures

Primary Outcomes (1)

• Ventilator-free days out of the first 28

Secondary Outcomes (7)

• Duration of delirium

• Length of hospitalization

• Cost of hospitalization

• 28-day mortality

• Usage of other sedatives

Interventions

Haloperidol DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanically ventilated within 24 hours of arrival to the ICU
• Delirium as assessed by CAM-ICU within 24 hours of arrival to the ICU
• Age \> 18

You may not qualify if:

• Known allergy to haloperidol or other neuroleptics
• Neurological injury or trauma
• \< 24 hours after a major operation
• History of Axis I psychiatric disorder or significant dementia
• Baseline QTc of \> 500 msec or a pacemaker which makes the QTc uninterpretable
• History of seizure disorder
• Morbid obesity (\> 1kg/cm body weight)
• Hepatic failure (Child's Class C)
• Neuromuscular disease (C5 or higher spinal cord injury, ALS, Guillain-Barre Syndrome, and myasthenia gravis)
• Malignancy or other irreversible disease or condition for which 6 month mortality is estimated to be ≥ 50%
• Pregnancy (negative pregnancy test required for women of child-bearing potential)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Denver Health Medical Center: collaborator

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Related Publications (3)

• Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.

  PMID: 11730446 BACKGROUND

• Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.

  PMID: 15082703 BACKGROUND

• Milbrandt EB, Kersten A, Kong L, Weissfeld LA, Clermont G, Fink MP, Angus DC. Haloperidol use is associated with lower hospital mortality in mechanically ventilated patients. Crit Care Med. 2005 Jan;33(1):226-9; discussion 263-5. doi: 10.1097/01.ccm.0000150743.16005.9a.

  PMID: 15644675 BACKGROUND

MeSH Terms

Conditions

Delirium; Critical Illness

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Study Officials

• Ivor S Douglas, MD

  University of Colorado Department of Pulmonary and Critical Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: February 1, 2007
• Study Start: December 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: November 14, 2012

Record last verified: 2009-11

Locations

US (1)