Postoperative Delirium in Hip Arthroplasty Patients

NCT ID: NCT02323984

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-03-31

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.

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)

Conditions

Delirium; Postoperative Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

miRNA Testing, Microemboli Monitoring, Delirium Assessment

Intervention Type: OTHER

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

miRNA Testing, Microemboli Monitoring, Delirium Assessment

Intervention Type: OTHER

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

miRNA Testing, Microemboli Monitoring, Delirium Assessment

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Nicoleta Stoicea

Co-Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fievos L Christofi, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2013H0291

Identifier Type: -

Identifier Source: org_study_id