Biological Aging, Medication, Malnutrition and Inflammation Among Acutely Ill and Healthy Elderly.
- Conditions
- MalnutritionAgingPolypharmacyInflammationEmergency Service, Hospital
- Registration Number
- NCT03052192
- Lead Sponsor
- Hvidovre University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 212
- ≥65 years
- Acute medical patient
- Understands and speaks Danish
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Eating validation scheme score 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) 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 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 From inclusion to 56 weeks after discharge Difference in NLRP3 inflammasome activity between groups.
Chronic inflammation From inclusion to 4 weeks after inclusion Stability and discriminative ability of new model for chronic inflammation (Control group 2)
- Secondary Outcome Measures
Name Time Method Cystatin C From inclusion to 56 weeks after discharge Quality of life From inclusion to 56 weeks after discharge EQ-5D-5L(EuroQol-5Dimentions-5Llevels), mini geriatric depression score
C-reactive protein (inflammation) From inclusion to 56 weeks after discharge Difference in inflammation between groups
Cytokine concentrations From inclusion to 56 weeks after discharge The concentration of cytokines at baseline and in response to stimulation will be measured
Cytometry From inclusion to 56 weeks after discharge Characterization of immune cell subsets
NF-kB activation From inclusion to 56 weeks after discharge The activation of NF-kB in response to stimulation.
Functional recovery score From inclusion to 56 weeks after discharge Assessing activities of daily living to characterize development in physical performance
Soluble urokinase plasminogen activator receptor (suPAR) (ng/ml) From inclusion to 56 weeks after discharge The plasma level of suPAR is a measure of inflammation and can be used to assess the difference in inflammation between groups
Bodyweight (kg) From inclusion to 4 and 56 weeks after discharge Development in bodyweight
Medication under-prescribing From inclusion to 4 weeks after discharge Assessment of underutilization Index (AOU)
Inflammation in malnourished patients 4 weeks after discharge Characterize the level of inflammation in malnourished patients
miRNA From inclusion to 56 weeks after discharge Levels of miRNA will be measured, and their association with NF-kB activity and biological ageing will be investigated.
Frequency of physicians' acceptance of suggested changes in medications At inclusion and at 4 weeks after discharge in the FAM group
Trial Locations
- Locations (1)
Amager & Hvidovre Hospital
🇩🇰Hvidovre, Region Hovedstaden, Denmark