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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00300391
• Other study ID #: 0505051
• Secondary ID: 1K23HL078760-01A
• Status: Terminated
• Phase: Phase 3
• First received: March 6, 2006
• Last updated: November 21, 2017
• Start date: March 2006
• Est. completion date: October 2011

Study information

• Verified date: November 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium

Intervention

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:
• Saline placebo
control arem

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day All-cause Mortality		Daily
Primary	90-day All-cause Mortality		90 Days from enrollment in study
Secondary	Duration of Mechanical Ventilation		daily
Secondary	ICU Length of Stay		Daily