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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00300391
First received: March 6, 2006
Last updated: October 13, 2008
Last verified: October 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium

Resource links provided by NLM:


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:
    Drug: haloperidol
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Eric B Milbrandt, MD, MPH University of Pittsburgh
  More Information

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

Keywords provided by University of Pittsburgh:
Delirium
Mechanical ventilation
Intensive care
Haloperidol

Additional relevant MeSH terms:
Delirium
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Haloperidol
Haloperidol decanoate
Anti-Dyskinesia Agents
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014