Clinical trial NCT02323984: Postoperative Delirium in Hip Arthroplasty Patients
Official title: Postoperative Delirium in Patients Undergoing Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Postoperative Complications
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 49
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects schedule to undergo hip arthroplasty surgery

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)

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

Primary outcomes:
measure: Identification of specific circulating microRNAs in post operative delirium patients
timeFrame: Baseline, perioperatively and during post operative hospitalization (Day 1 and Day 2 post surgery)
Secondary outcomes:
measure: Age effects on cognitive function (cognitive reserve)
timeFrame: Baseline
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Fievos L Christofi, PhD
role: PRINCIPAL_INVESTIGATOR
References: