Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy (PE-POD)
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|ClinicalTrials.gov Identifier: NCT02213900|
Recruitment Status : Completed
First Posted : August 12, 2014
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.
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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Babar A Khan, MD, MS||Regenstrief Institute, Inc.|
|Principal Investigator:||Kenneth A Kesler, MD||IU School of Medicine|