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Clinical Trials/NCT03052192
NCT03052192
Unknown
Not Applicable

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

Hvidovre University Hospital1 site in 1 country212 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
Hvidovre University Hospital
Enrollment
212
Locations
1
Primary Endpoint
Eating validation scheme score
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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: Chronic inflammation and biological aging promote the development of age-related chronic diseases. There is a large variation in the rate of aging between individuals, in particular among the elderly. This means that the chronological age of a person often does not reflect its true state of aging, the biological age. This challenges the ability to provide appropriate care and to predict responses to treatment and interventions in elderly patients. The underlying causes and mechanisms of biological aging and chronic inflammation are not well understood. There are currently no validated methods for measuring biological age and no measures of chronic inflammation which can be used in an acute setting. Here, the investigators aim to test a novel model for chronic inflammation and investigate the role of the NLRP3 inflammasome, NFkB (nuclear factor kappa light chain enhancer of activated B cells) and miRNAs in biological aging and chronic inflammation. The study is prospective with 3 groups of study participants: one group is included in the Acute Medical Department and two healthy control groups (one young and one older). The follow-up comprises two predefined examinations and any readmissions at our hospital. Furthermore, participants are followed in the national registries.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
December 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ove Andersen

Head of Clinical Research Centre

Hvidovre University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Eating validation scheme score

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: From inclusion to 56 weeks after discharge

Difference in NLRP3 inflammasome activity between groups.

Chronic inflammation

Time Frame: From inclusion to 4 weeks after inclusion

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

Secondary Outcomes

  • 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)

Study Sites (1)

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