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临床试验/NCT02323984
NCT02323984已完成不适用

Postoperative Delirium in Patients Undergoing Hip Arthroplasty

Ohio State University1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
1
主要终点
Identification of specific circulating microRNAs in post operative delirium patients

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Identification of specific circulating microRNAs in post operative delirium patients

时间窗: 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)

次要结局

  • Age effects on cognitive function (cognitive reserve)(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicoleta Stoicea

Co-Principal Investigator

Ohio State University

研究点 (1)

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