Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy (PE-POD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02213900
Recruitment Status : Completed
First Posted : August 12, 2014
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Babar Khan, MD, MS, Regenstrief Institute, Inc.

Brief Summary:

The purpose of this study is to investigate the effectiveness of a preventative low-dose of Haloperidol to prevent delirium in patients undergoing a esophagectomy, pneumonectomy or thoracotomy.

Delirium is state of severe confusion and some symptoms include:

  • Cannot think clearly
  • Have trouble paying attention
  • Have a hard time understanding what is going on around them
  • May see or hear things that are not there. These things seem very real to them.

Condition or disease Intervention/treatment Phase
Delirium Cognitive Impairment Post-traumatic Stress Disorder Depression Anxiety Drug: Haloperidol Drug: Placebo Phase 4

Detailed Description:

50% of patients who undergo esophageal and/or lung resection suffer from acute brain dysfunction or delirium postoperatively. Delirium is a state of brain failure characterized by disturbance of consciousness with reduced ability to focus, sustain, or shift attention that occurs over a short period of time and tends to fluctuate over the course of the day. Presence of delirium in the post-operative phase is associated with a longer length of both intensive care unit and hospital stay, increased health-care costs, long-term functional and cognitive decline, and an increased risk of in-hospital and post-discharge mortality.

Haloperidol primarily acts by blocking dopamine (D2) receptors. This dopamine blockade in the cerebral cortex improves cognition and reduces delirium. Along with the dopamine blockade, haloperidol has anti-inflammatory properties. It inhibits production of lipopolysaccharide induced pro-inflammatory cytokines, interleukin (IL-1) and tumor necrosis factor alpha (TNF-α). Haloperidol also increases levels of Interleukin -1 receptor antagonist (IL-1RA), an anti-inflammatory cytokine that blocks the action of other pro-inflammatory cytokines. If unchecked, the inflammatory cytokines cause impaired concentration, sleep disturbances, and agitation the cardinal symptoms of delirium; and induce a reduction in cholinergic activity. Given the inhibitory effect of acetylcholine on certain cytokines such as interleukin-6, a repetitive cycle of inadequate regulation of inflammation due to cholinergic depletion ensues. Haloperidol with its anti-inflammatory properties seeks to mitigate this repetitive vicious cycle.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Post-Operative Delirium in Pneumonectomy, Esophagectomy and Thoracotomy Patients
Study Start Date : September 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Haloperidol
Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.
Drug: Haloperidol
0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days

Placebo Comparator: Placebo
Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.
Drug: Placebo



Primary Outcome Measures :
  1. Efficacy of Low-dose Haloperidol in Reducing Delirium Incidence [ Time Frame: Up to 30 days ]
    Test the efficacy of low dose haloperidol in reducing delirium incidence among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo.


Secondary Outcome Measures :
  1. Efficacy of Low-dose Haloperidol in Reducing Days With Delirium [ Time Frame: Up to 30 days ]
    Test the efficacy of low dose haloperidol in reducing the number of days with delirium among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo.

  2. Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay [ Time Frame: Date of hospital admission through date of hospital discharge, up to 3 weeks on average. ]
    Test the efficacy of low dose haloperidol in reducing ICU and hospital length of stay among patients who are status post esophagectomy or pneumonectomy compared to placebo.

  3. Efficacy of Low-dose Haloperidol in Reducing Cognitive Impairment at Post-operative Follow-up [ Time Frame: Up to 3 months after hospital discharge on average. ]
    Test the efficacy of low dose haloperidol in reducing cognitive impairment at post-operative follow-up among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo. Cognitive status is assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS measures attention, language, visuospatial/constructional abilities, and memory. It is made up of 12 subtests. The subtests produce 5 index scores and a total scale score. All the subtest scores are summed to calculate a Total Index score. The Total Index score is presented. The Total Index score scale is from 0-100 with higher scores indicating less cognitive impairment.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least ≥ 18 years of age and older
  2. Undergoing a possible or scheduled thoracotomy
  3. English speaking

Exclusion Criteria:

  1. History of Schizophrenia and Parkinson's disease
  2. History of Severe Dementia
  3. History of Alcohol Abuse
  4. On Cholinesterase Inhibitors or Levodopa
  5. Pregnant or Nursing
  6. Corrected QT interval > 550 milliseconds at the time of randomization
  7. History of Neuroleptic Malignant Syndrome or Haloperidol Allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213900


Locations
Layout table for location information
United States, Indiana
University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Layout table for investigator information
Principal Investigator: Babar A Khan, MD, MS Regenstrief Institute, Inc.
Principal Investigator: Kenneth A Kesler, MD IU School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Babar Khan, MD, MS, Principle Investigator, Regenstrief Institute, Inc.
ClinicalTrials.gov Identifier: NCT02213900     History of Changes
Other Study ID Numbers: VFR-398-Khan
First Posted: August 12, 2014    Key Record Dates
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017
Last Verified: March 2017
Keywords provided by Babar Khan, MD, MS, Regenstrief Institute, Inc.:
delirium
confusion
surgery
cognitive Impairment
post-traumatic Stress disorder
depression
anxiety
Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Depression
Cognitive Dysfunction
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Trauma and Stressor Related Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action