Postoperative Delirium in Hip Arthroplasty Patients (mRNAOrtho)

Postoperative Delirium in Patients Undergoing Hip Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Delirium
• Intervention / Treatment: 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)

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects schedule to undergo hip arthroplasty surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of specific circulating microRNAs in post operative delirium patients	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)	Baseline, perioperatively and during post operative hospitalization (Day 1 and Day 2 post surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age effects on cognitive function (cognitive reserve)	We will explore age effect on cognitive function (cognitive reserve), based on the baselin cognitive assessment score.	Baseline

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Fievos L Christofi, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: December 23, 2014
• First Posted (Estimate): December 24, 2014

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 18, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Postoperative Complications
• Other Study ID Numbers: 2013H0291