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Completed

NCT Number: NCT02323984

Postoperative Delirium in Hip Arthroplasty 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. 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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

miRNA Testing, Microemboli Monitoring, Delirium Assessment

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).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Postoperative Delirium in Patients Undergoing Hip Arthroplasty

Acronym: mRNAOrtho

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 24, 2014
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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