Pilot Study of Haloperidol to Treat Critical Illness Delirium

This study has been completed.
Sponsor:
Collaborator:
Denver Health Medical Center
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00429676
First received: January 30, 2007
Last updated: November 13, 2012
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Delirium
Critical Illness
Drug: Haloperidol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Prospective Pilot Study Of Haloperidol In Addition To Standard Sedation In Mechanically Ventilated Patients With Delirium

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Ventilator-free days out of the first 28

Secondary Outcome Measures:
  • Duration of delirium
  • Length of hospitalization
  • Cost of hospitalization
  • 28-day mortality
  • 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

Estimated Enrollment: 20
Study Start Date: December 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429676

Locations
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
University of Colorado, Denver
Denver Health Medical Center
Investigators
Principal Investigator: Ivor S Douglas, MD University of Colorado Department of Pulmonary and Critical Care Medicine
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00429676     History of Changes
Other Study ID Numbers: 05-0362
Study First Received: January 30, 2007
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Randomized
Controlled
Trial
Delirium
Haloperidol

Additional relevant MeSH terms:
Critical Illness
Delirium
Disease Attributes
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on August 27, 2014