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

NCT00300391 | Terminated Phase 3 Results DMC

• 2 other identifiers: 05050511K23HL078760-01A1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Delirium

Keywords

Delirium; Mechanical ventilation; Intensive care; Haloperidol

Outcome Measures

Primary Outcomes (2)

• 28-day All-cause Mortality

  Daily

• 90-day All-cause Mortality

  90 Days from enrollment in study

Secondary Outcomes (2)

• Duration of Mechanical Ventilation

  daily

• ICU Length of Stay

  Daily

Study Arms (2)

haloperidol

EXPERIMENTAL

Once diagnosed as delirious, randomized to haloperidol 5 mg IV

Drug: haloperidol

placebo

PLACEBO COMPARATOR

once diagnosed as delirious, received 5 mg saline placebo

Other: Saline placebo

Interventions

haloperidol 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.

Also known as: Haldol

haloperidol

Saline placebo OTHER

control arem

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Publications (1)

• 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.

  PMID: 15644675 BACKGROUND

MeSH Terms

Conditions

Delirium

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Limitations and Caveats

This study was pre-maturely terminated. Although sincere efforts were made to locate the relevant and accurate data, limited data could be obtained. Also, conflicting information was available with respect to participant enrollment.

Results Point of Contact

• Title: Barb Early, RN, BSN, CCRC
• Organization: UPittsburgh

earlybj@upmc.edu

(412) 647-9745

Study Officials

• Eric B Milbrandt, MD, MPH

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MACRO Clinical Director

Study Record Dates

• First Submitted: March 6, 2006
• First Posted: March 8, 2006
• Study Start: March 1, 2006
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 20, 2017
• Results First Posted: December 20, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share