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:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by:

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00300391

First received: March 6, 2006

Last updated: October 13, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 6, 2006

Last Updated Date

October 13, 2008

Start Date ^ICMJE

March 2006

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

28-day all-cause mortality
90-day all-cause mortality

Change History

Complete list of historical versions of study NCT00300391 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Total delirium days
Duration of mechanical ventilation
ICU length of stay

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Delirium

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

304

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00300391

Other Study ID Numbers ^ICMJE

0505051, NHLBI, 1 K23 HL078760-01A1

Has Data Monitoring Committee

Yes

Responsible Party

Eric B. Milbrant, MD,MPH, University of Pittsburgh ,Department of Critical Care

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Investigators ^ICMJE

Principal Investigator:

Eric B Milbrandt, MD, MPH

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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