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临床试验/NCT03052192
NCT03052192Unknown不适用

Biological Aging, Medication, Malnutrition and Inflammation Among Acutely Ill and Healthy Elderly.

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
212
试验地点
1
主要终点
Eating validation scheme score

研究概览

简要总结

In this study, the investigators will investigate and characterize acute medical patients in order to optimize patient courses in the acute care departments, especially with regard to polypharmacy and undernourishment. In addition, the investigators will investigate underlying immunological mechanisms of chronic inflammation and biological aging in this population to improve the current knowledge and possibilities for preventing chronic diseases and acute hospitalization.

详细描述

Malnutrition:

Malnutrition among elderly is associated with frailty, including loss of weight, muscle mass, function and quality of life and also with an increased number of hospital admissions. In this study, the investigators aim to describe the development of and the risk factors for malnutrition from admission to 4 weeks after discharge, in addition the investigators wish to characterize the inflammatory state of the malnourished patients.

Inappropriate polypharmacy:

The broad variation among elderly in health, number of chronic diseases, organ function, biological age and function makes the prescription of drugs to this population a very complex task with a high risk of inappropriate medication. 5-30% of all non-elective admissions are caused by inappropriate medications, and many of these are preventable. Therefore, the investigators aim to investigate the feasibility of a pharmacist-geriatrician medication review in the acute care department and the effect on the Medication Appropriateness Index score (MAI-score) .

Chronic inflammation and biological aging:

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
20 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥65 years
  • Acute medical patient
  • Understands and speaks Danish

排除标准

  • Unable to cooperate cognitively
  • Terminal patients
  • Patients in isolation
  • Control group 1:
  • Inclusion Criteria:
  • ≥65 years
  • No hospital admissions within the past 2 years
  • Exclusion Criteria:
  • Acute admissions within the past 2 years
  • Auto-immune diseases
  • Treatment with immunosuppressive or biological therapies
  • Control group 2:
  • Inclusion Criteria:
  • 20-35 years
  • Caucasian
  • No admissions due to chronic or critical illness within the past 5 years (except admissions related to child birth, abortion, appendicitis, poisoning, traumas, concussion etc.)
  • Exclusion Criteria:
  • Auto-immune or chronic diseases

结局指标

主要结局

Eating validation scheme score

时间窗: From inclusion to 4 weeks after discharge

Development in nutritional status and risk factors of malnutrition within the FAM group.

MAI score (Medication Appropriateness Index)

时间窗: From inclusion to 4 weeks after discharge

Difference in summed MAI-score per patient. MAI score between inclusion and first follow-up visit (FAM group)

NF-kB (Nuclear Factor Kappa light chain enhancer og activated B cells) activity

时间窗: From inclusion to 56 weeks after discharge

The development in NF-kB activity between the groups will be investigated. The association of NF-kB activity with biological ageing-measured by chronic inflammation, and loss of function and cognition-will also be investigated.

NLRP3 activity

时间窗: From inclusion to 56 weeks after discharge

Difference in NLRP3 inflammasome activity between groups.

Chronic inflammation

时间窗: From inclusion to 4 weeks after inclusion

Stability and discriminative ability of new model for chronic inflammation (Control group 2)

次要结局

  • Quality of life(From inclusion to 56 weeks after discharge)
  • Functional recovery score(From inclusion to 56 weeks after discharge)
  • Cystatin C(From inclusion to 56 weeks after discharge)
  • Cytokine concentrations(From inclusion to 56 weeks after discharge)
  • Cytometry(From inclusion to 56 weeks after discharge)
  • NF-kB activation(From inclusion to 56 weeks after discharge)
  • C-reactive protein (inflammation)(From inclusion to 56 weeks after discharge)
  • Soluble urokinase plasminogen activator receptor (suPAR) (ng/ml)(From inclusion to 56 weeks after discharge)
  • Bodyweight (kg)(From inclusion to 4 and 56 weeks after discharge)
  • Medication under-prescribing(From inclusion to 4 weeks after discharge)
  • Inflammation in malnourished patients(4 weeks after discharge)
  • miRNA(From inclusion to 56 weeks after discharge)
  • Frequency of physicians' acceptance of suggested changes in medications(At inclusion and at 4 weeks after discharge in the FAM group)

研究者

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

Ove Andersen

Head of Clinical Research Centre

Hvidovre University Hospital

研究点 (1)

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