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

Information source: Regenstrief Institute, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Delirium; Cognitive Impairment; Post-traumatic Stress Disorder; Depression; Anxiety

Intervention: Haloperidol (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Regenstrief Institute, Inc.

Official(s) and/or principal investigator(s):
Babar A Khan, MD, MS, Principal Investigator, Affiliation: Regenstrief Institute, Inc.
Kenneth A Kesler, MD, Principal Investigator, Affiliation: IU School of Medicine

Overall contact:
Teresa Smith, BS, Phone: 317-274-9259, Email: smithten@iupui.edu

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.

Clinical Details

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

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

Primary outcome: Efficacy of low-dose Haloperidol in reducing delirium incidence

Secondary outcome:

Efficacy of low-dose Haloperidol in reducing delirium duration and severity

Efficacy of low-dose Haloperidol in reducing ICU and hospital length of stay

Efficacy of low-dose Haloperidol in reducing cognitive impairment at post-operative follow-up

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Teresa Smith, BS, Phone: 317-274-9259, Email: smithten@iupui.edu

University Hospital, Indianapolis, Indiana 46202, United States; Recruiting
Babar A Khan, MD, MS, Phone: 317-274-9132, Email: bakhan@iupui.edu
Tiffany L Campbell, BS, Phone: 317-274-9052, Email: tiffcamp@iupui.edu
Babar A Khan, MD, MS, Principal Investigator
Additional Information

Starting date: September 2013
Last updated: August 11, 2014

Page last updated: August 23, 2015

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