NCT02213900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 13, 2017

Completed
Last Updated

April 13, 2017

Status Verified

March 1, 2017

Enrollment Period

2.2 years

First QC Date

March 18, 2014

Results QC Date

December 30, 2016

Last Update Submit

March 2, 2017

Conditions

DeliriumCognitive ImpairmentPost-traumatic Stress DisorderDepressionAnxiety

Keywords

deliriumconfusionsurgerycognitive Impairmentpost-traumatic Stress disorderdepressionanxiety

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Efficacy of Low-dose Haloperidol in Reducing Days With Delirium

    Up to 30 days

  • Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay

    Date of hospital admission through date of hospital discharge, up to 3 weeks on average.

  • Efficacy of Low-dose Haloperidol in Reducing Cognitive Impairment at Post-operative Follow-up

    Up to 3 months after hospital discharge on average.

Study Arms (2)

Haloperidol

EXPERIMENTAL

Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.

Drug: Haloperidol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

HaloperidolDRUG

0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days

Haloperidol
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least ≥ 18 years of age and older
  • Undergoing a possible or scheduled thoracotomy
  • English speaking

You may not qualify if:

  • History of Schizophrenia and Parkinson's disease
  • History of Severe Dementia
  • History of Alcohol Abuse
  • On Cholinesterase Inhibitors or Levodopa
  • Pregnant or Nursing
  • Corrected QT interval \> 550 milliseconds at the time of randomization
  • History of Neuroleptic Malignant Syndrome or Haloperidol Allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Khan BA, Perkins AJ, Campbell NL, Gao S, Khan SH, Wang S, Fuchita M, Weber DJ, Zarzaur BL, Boustani MA, Kesler K. Preventing Postoperative Delirium After Major Noncardiac Thoracic Surgery-A Randomized Clinical Trial. J Am Geriatr Soc. 2018 Dec;66(12):2289-2297. doi: 10.1111/jgs.15640. Epub 2018 Nov 21.

    PMID: 30460981DERIVED

MeSH Terms

Conditions

DeliriumCognitive DysfunctionStress Disorders, Post-TraumaticDepressionAnxiety DisordersConfusion

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersCognition DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic Chemicals

Results Point of Contact

Title
Babar Khan, MD
Organization
Indiana University
bakhan@iu.edu
317-274-9132

Study Officials

  • Babar A Khan, MD, MS

    Regenstrief Institute, Inc.

    PRINCIPAL INVESTIGATOR

  • Kenneth A Kesler, MD

    IU School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 18, 2014

First Posted

August 12, 2014

Study Start

September 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 13, 2017

Results First Posted

April 13, 2017

Record last verified: 2017-03

Locations

US(1)