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

Primary Purpose

Delirium

Status

Terminated

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

haloperidol

Saline placebo

About this trial

This is an interventional treatment trial for Delirium focused on measuring Delirium, Mechanical ventilation, Intensive care, Haloperidol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

haloperidol

placebo

Arm Description

Once diagnosed as delirious, randomized to haloperidol 5 mg IV

once diagnosed as delirious, received 5 mg saline placebo

Outcomes

Primary Outcome Measures

28-day All-cause Mortality

90-day All-cause Mortality

Secondary Outcome Measures

Duration of Mechanical Ventilation

ICU Length of Stay

Full Information

NCT ID

NCT00300391

First Posted

March 6, 2006

Last Updated

November 21, 2017

Sponsor

University of Pittsburgh

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT00300391

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Terminated

Why Stopped

Insufficient recruitment to meet aims.

Study Start Date

March 2006 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Delirium

Keywords

Delirium, Mechanical ventilation, Intensive care, Haloperidol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

haloperidol

Arm Type

Experimental

Arm Description

Once diagnosed as delirious, randomized to haloperidol 5 mg IV

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

once diagnosed as delirious, received 5 mg saline placebo

Intervention Type

Drug

Intervention Name(s)

haloperidol

Other Intervention Name(s)

Haldol

Intervention Description

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

Other

Intervention Name(s)

Saline placebo

Intervention Description

control arem

Primary Outcome Measure Information:

Title

28-day All-cause Mortality

Time Frame

Daily

Title

90-day All-cause Mortality

Time Frame

90 Days from enrollment in study

Secondary Outcome Measure Information:

Title

Duration of Mechanical Ventilation

Time Frame

daily

Title

ICU Length of Stay

Time Frame

Daily

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric B Milbrandt, MD, MPH

Organizational Affiliation

University of Pittsburgh Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15644675

Citation

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.

Results Reference

background

Learn more about this trial

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

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