ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium - Full Text View

Sponsors and Collaborators:	University of Pittsburgh National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00300391

Purpose

The purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality.

Condition	Intervention	Phase
Delirium	Drug: haloperidol	Phase II

Drug Information available for: Haloperidol Haloperidol decanoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

28-day all-cause mortality [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
90-day all-cause mortality [ Time Frame: 90 Days from enrollment in study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total delirium days [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
Duration of mechanical ventilation [ Time Frame: daily ] [ Designated as safety issue: Yes ]
ICU length of stay [ Time Frame: Daily ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	304
Study Start Date:	March 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay.

Detailed Description:

Intensive care unit delirium is a serious medical condition that is associated with increased morbidity and mortality. In this study, 304 delirious mechanically ventilated subjects will be randomized to haloperidol 5mg IV every 12 hours or placebo to determine if treatment with haloperidol improves short and long-term mortality.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All adult (>=18 years of age) mechanically ventilated patients admitted to the medical, surgical, trauma, or cardiothoracic ICUs of the UPMC main campus who are expected by the ICU clinical team to require >24 hours of mechanical ventilation

Exclusion Criteria:

Baseline QTc >480 milliseconds (ms); history of Parkinson's disease; pregnancy; history of schizophrenia or neurologic disease that would confound the delirium assessment; deafness or inability to understand English or Spanish; extubation prior to enrollment; previously enrolled in this study; patient, family, or attending physician refusal; death before enrollment; treatment with haloperidol within 2 days prior to ICU admission; and prisoners.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300391

Contacts

Contact: Barbara J Early, BSN	412 647 9745	earlybj@upmc.edu
Contact: Tina M Vita, RN	412 647 9652	vitatm@upmc.edu

Locations

United States, Pennsylvania
Presbyterian, UPMC	Recruiting
Pittsburgh, Pennsylvania, United States, 15261

Sponsors and Collaborators

University of Pittsburgh

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Eric B Milbrandt, MD, MPH

University of Pittsburgh

More Information

Publications:

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.

Responsible Party:	University of Pittsburgh ,Department of Critical Care ( Eric B. Milbrant, MD,MPH )
Study ID Numbers:	0505051, NHLBI, 1 K23 HL078760-01A1
Study First Received:	March 6, 2006
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00300391
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:

Delirium
Mechanical ventilation
Intensive care
Haloperidol

Study placed in the following topic categories:

Haloperidol
Signs and Symptoms
Haloperidol decanoate
Dopamine
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

Neurologic Manifestations
Confusion
Dementia
Neurobehavioral Manifestations
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics

Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009