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

NCT ID: NCT00300391

Last Updated: 2017-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2011-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Delirium

Keywords

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Delirium Mechanical ventilation Intensive care Haloperidol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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haloperidol

Once diagnosed as delirious, randomized to haloperidol 5 mg IV

Group Type EXPERIMENTAL

haloperidol

Intervention Type DRUG

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.

placebo

once diagnosed as delirious, received 5 mg saline placebo

Group Type PLACEBO_COMPARATOR

Saline placebo

Intervention Type OTHER

control arem

Interventions

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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.

Intervention Type DRUG

Saline placebo

control arem

Intervention Type OTHER

Other Intervention Names

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Haldol

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Barb Early

MACRO Clinical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric B Milbrandt, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15644675 (View on PubMed)

Other Identifiers

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1K23HL078760-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0505051

Identifier Type: -

Identifier Source: org_study_id