Postoperative Delirium in Hip Arthroplasty Patients

Delirium Clinical Trial

— mRNAOrtho  

Official title:

Postoperative Delirium in Patients Undergoing Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323984
• Other study ID #: 2013H0291
• Status: Completed
• Phase: N/A
• First received: December 16, 2014
• Last updated: January 18, 2017
• Start date: January 2014
• Est. completion date: March 2016

Study information

• Verified date: January 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Postoperative Complications

Intervention

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).

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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