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Postoperative Delirium in Hip Arthroplasty Patients (mRNAOrtho)

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: NCT02323984
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Nicoleta Stoicea, Ohio State University

Brief Summary:
Identification of specific circulating microRNAs and microemboli formation (diagnosed by TC Doppler) in both delirious groups and nondelirious group will be our primary target. Delirium assessment through standardized questionnaires will be done at baseline (day of the surgery - pre operatory), immediately after surgery (in post anesthesia care unit) and then every 12 hours in Day 1 and Day2 after surgery. The investigators will use linear mixed models to describe the change patterns overtime, and compare differences at each time point. Inflammatory biomarkers will be explored overtime as well. The investigators will also explore age effect on cognitive function - cognitive reserve - based on the score of the cognitive test administered at baseline.

Condition or disease Intervention/treatment
Delirium Postoperative Complications Other: miRNA Testing, Microemboli Monitoring, Delirium Assessment

Detailed Description:

Specific circulating microRNA's have been identified in patients with neurological diseases or deficits, and specifically those with neurodegenerative conditions. Furthermore, available evidence primarily in pre-clinical / animal models supports the hypothesis that post-surgical/anesthesia - induced neuroinflammation leads to post-operative cognitive decline or dysfunction. The investigators hypothesize that specific circulating microRNA's involved in the pro-inflammatory response to surgery/anesthesia are a suitable biomarker of Delirium and/or POCD in surgical hip-arthroplasty patients. However, it is also possible that microamboli during the surgical procedure could contribute to these neurologic outcomes. Therefore, in addition to analyzing microRNA levels (our primary target), the investigators propose to monitor cerebral vascular flow during the surgery to possibly identify microambolic events using Transcranial Doppler. Overall, our overarching goal is to identify novel early clinical indicators of cognitive dysfunction (e.g. Delirium and POCD).

The study will include preoperative-postoperative trajectory as well as the value of using subjects as self-controls with appropriate longitudinal analyses of cognition.

There are many factors that are potential confounders in relation to cognitive decline and incident dementia.

There are key characteristics and events:

  • illnesses requiring hospitalization, that could potentially accelerate cognitive decline or worsen clinical dementia rating
  • which anesthetic agents are administered for the surgical procedure
  • intra-operative adverse events (anesthesia/surgery related, cerebral hypoxia, hypotension/hypertension, blood loss)
  • patient factors (age, education, comorbidity)
  • physiologic factors (inflammation,micro-embolization, blood-brain barrier function);
  • perioperative factors (medications, sleep, complications)
  • postoperative factors (rehabilitation, depression, social support)

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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Delirium in Patients Undergoing Hip Arthroplasty
Study Start Date : January 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort Intervention/treatment
Hypoactive Delirium - Delirious
Hypoactive delirious patients presenting with lethargy and sedation and are slow to respond to questions and demonstrate little spontaneous movement. miRNA Testing, Microemboli Monitoring, Delirium Assessment will be performed
Other: miRNA Testing, Microemboli Monitoring, Delirium Assessment
Delirium assessment questionnaire and blood testing for miRNA will be done for all patients postoperatively, as well as BIS monitoring during surgery. The three arms of the study indicate the allocation of each patient based on their delirium presentation (hypoactive, hyperactive, or none).

Hyperactive Delirium - Delirious
Hyperactive delirious patients presenting with restlessness, agitation, hyper vigilance, and occaionally hallucinations. miRNA Testing, Microemboli Monitoring, Delirium Assessment will be performed
Other: miRNA Testing, Microemboli Monitoring, Delirium Assessment
Delirium assessment questionnaire and blood testing for miRNA will be done for all patients postoperatively, as well as BIS monitoring during surgery. The three arms of the study indicate the allocation of each patient based on their delirium presentation (hypoactive, hyperactive, or none).

No Delirium - Nondelirious
Patients not presenting any symptoms of hypoactive or hyperactive postoperative delirium. miRNA Testing, Microemboli Monitoring, Delirium Assessment will be performed
Other: miRNA Testing, Microemboli Monitoring, Delirium Assessment
Delirium assessment questionnaire and blood testing for miRNA will be done for all patients postoperatively, as well as BIS monitoring during surgery. The three arms of the study indicate the allocation of each patient based on their delirium presentation (hypoactive, hyperactive, or none).




Primary Outcome Measures :
  1. Identification of specific circulating microRNAs in post operative delirium patients [ Time Frame: Baseline, perioperatively and during post operative hospitalization (Day 1 and Day 2 post surgery) ]
    Identification of specific circulating microRNAs and microemboli formation (diagnosed by TC Doppler) in both delirious groups and nondelirious group will be our primary target. Our overarching goal is to identify novel early clinical indicators of cognitive dysfunction (e.g. Delirium and POCD)


Secondary Outcome Measures :
  1. Age effects on cognitive function (cognitive reserve) [ Time Frame: Baseline ]
    We will explore age effect on cognitive function (cognitive reserve), based on the baselin cognitive assessment score.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects schedule to undergo hip arthroplasty surgery
Criteria

Inclusion Criteria:

  • Male or female, between 30 and 80 years of age
  • ASA I , II or III
  • Capable and willing to consent
  • Participants literate in English language

Exclusion Criteria:

  • ASA IV or V
  • Patients with severe visual or auditory disorder
  • Illiteracy
  • Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
  • Dementia of Alzheimer's type
  • Parkinson disease
  • Multiple Sclerosis (MS)
  • Vascular dementia

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): NCT02323984


Locations
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United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Fievos L Christofi, PhD Ohio State University
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Responsible Party: Nicoleta Stoicea, Co-Principal Investigator, Ohio State University
ClinicalTrials.gov Identifier: NCT02323984    
Other Study ID Numbers: 2013H0291
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Delirium
Postoperative Complications
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Pathologic Processes