Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy

Depression Clinical Trial

— PE-POD  

Official title:

Preventing Post-Operative Delirium in Pneumonectomy, Esophagectomy and Thoracotomy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213900
• Other study ID #: VFR-398-Khan
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2014
• Last updated: February 9, 2016
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Cognition Disorders
• Cognitive Impairment
• Delirium
• Depression
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Haloperidol
0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days
• Placebo

Locations

Country	Name	City	State
United States	University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of low-dose Haloperidol in reducing delirium incidence	Test the efficacy of low dose haloperidol in reducing delirium incidence among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo.	Up to 30 days	No
Secondary	Efficacy of low-dose Haloperidol in reducing delirium duration and severity	Test the efficacy of low dose haloperidol in reducing delirium duration and severity among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo.	Up to 30 days	No
Secondary	Efficacy of low-dose Haloperidol in reducing ICU and hospital length of stay	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.	Date of hospital admission through date of hospital discharge, up to 3 weeks on average.	No
Secondary	Efficacy of low-dose Haloperidol in reducing cognitive impairment at post-operative follow-up	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.	Up to 3 months after hospital discharge on average.	No