Pilot Study of Haloperidol to Treat Critical Illness Delirium

November 13, 2012 updated by: University of Colorado, Denver

A Randomized Prospective Pilot Study Of Haloperidol In Addition To Standard Sedation In Mechanically Ventilated Patients With Delirium

The goal of this study is to determine whether haloperidol reduces the time on the breathing machine in critically ill patients with delirium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Delirium is a frequent end-organ complication of critical illness and is an independent predictor of mortality in mechanically ventilated patients. However, management of delirium is a major therapeutic challenge and it is unknown if current therapies are disease modifying or function only as symptom management. Haloperidol has been demonstrated to reduce delirium in retrospective studies.

This study is a pilot prospective randomized clinical trial in the Denver Health Medical ICU to determine if haloperidol in addition to an evidence-based standard-of-care sedation protocol for the management of delirium results in a shortened duration of intubation and improvements in post-extubation cognitive status. The haloperidol dose is administered using titration-protocol guided by nursing assessment of delirium using the confusion assessment method for the ICU (CAM-ICU). The primary outcome is ventilator-free days out of the first 28, and secondary outcomes include duration of delirium, length and cost of hospitalization, 28-day mortality, usage of other sedatives, serum markers of delirium (neuron-specific enolase and protein S-100B), and cognitive-function scores at the time of ICU discharge, hospital discharge, and six-month follow-up.

The goal of the 20-patient pilot is demonstrating safety of the haloperidol protocol, as evaluated by an independent data-safety monitoring board. Following approval of the DSMB, 122 more patients will be enrolled in the full RCT to achieve power for an 80% chance of detecting a 40% decrease in duration of intubation with P < 0.05.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mechanically ventilated within 24 hours of arrival to the ICU
  • Delirium as assessed by CAM-ICU within 24 hours of arrival to the ICU
  • Age > 18

Exclusion Criteria:

  • Known allergy to haloperidol or other neuroleptics
  • Neurological injury or trauma
  • < 24 hours after a major operation
  • History of Axis I psychiatric disorder or significant dementia
  • Baseline QTc of > 500 msec or a pacemaker which makes the QTc uninterpretable
  • History of seizure disorder
  • Morbid obesity (> 1kg/cm body weight)
  • Hepatic failure (Child's Class C)
  • Neuromuscular disease (C5 or higher spinal cord injury, ALS, Guillain-Barre Syndrome, and myasthenia gravis)
  • Malignancy or other irreversible disease or condition for which 6 month mortality is estimated to be ≥ 50%
  • Pregnancy (negative pregnancy test required for women of child-bearing potential)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ventilator-free days out of the first 28

Secondary Outcome Measures

Outcome Measure
Length of hospitalization
28-day mortality
Duration of delirium
Cost of hospitalization
Usage of other sedatives
Serum markers of delirium (neuron-specific enolase and protein S-100B)
Cognitive-function scores at the time of ICU discharge, hospital discharge, and six-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Denver Health Medical Center

Investigators

  • Principal Investigator: Ivor S Douglas, MD, University of Colorado Department of Pulmonary and Critical Care Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

January 30, 2007

First Submitted That Met QC Criteria

January 31, 2007

First Posted (Estimate)

February 1, 2007

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-0362

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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