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

This study has been terminated.
(Insufficient recruitment to meet aims.)
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Barb Early, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00300391
First received: March 6, 2006
Last updated: May 10, 2016
Last verified: May 2016
  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 Other: Saline placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 Barb Early, University of Pittsburgh:

Primary Outcome Measures:
  • 28-day all-cause mortality [ Time Frame: Daily ]
  • 90-day all-cause mortality [ Time Frame: 90 Days from enrollment in study ]

Secondary Outcome Measures:
  • Total delirium days [ Time Frame: Daily ]
  • Duration of mechanical ventilation [ Time Frame: daily ]
  • ICU length of stay [ Time Frame: Daily ]

Enrollment: 40
Study Start Date: March 2006
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: haloperidol
Once diagnosed as delirious, randomized to haloperidol 5 mg IV
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.
Other Name: Haldol
Placebo Comparator: placebo
once diagnosed as delirious, received 5 mg saline placebo
Other: Saline placebo
control arem

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

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:
Responsible Party: Barb Early, MACRO Clinical Director, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00300391     History of Changes
Other Study ID Numbers: 0505051
1K23HL078760-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: March 6, 2006
Last Updated: May 10, 2016
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on June 28, 2017