Clinical trial NCT03052192: Biological Aging, Medication, Malnutrition and Inflammation Among Acutely Ill and Healthy Elderly.
Official title: Biological Aging, Medication, Malnutrition and Inflammation Among Acutely Ill and Healthy Elderly.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aging
Polypharmacy
Malnutrition
Inflammation
Emergency Service, Hospital
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Clinical Research Centre
name: Lundbeck Foundation
name: Region Hovedstadens Apotek
First posted: 2017-02-14
Enrollment: 212
Sex: ALL
Minimum age (years): 20
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Three study groups; the FAM group, control group 1 and control group 2

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.

Eligibility criteria: FAM group:

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
* 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

Primary outcomes:
measure: Eating validation scheme score
timeFrame: From inclusion to 4 weeks after discharge
measure: MAI score (Medication Appropriateness Index)
timeFrame: From inclusion to 4 weeks after discharge
measure: NF-kB (Nuclear Factor Kappa light chain enhancer og activated B cells) activity
timeFrame: From inclusion to 56 weeks after discharge
measure: Chronic inflammation
timeFrame: From inclusion to 4 weeks after inclusion
measure: NLRP3 activity
timeFrame: From inclusion to 56 weeks after discharge
Secondary outcomes:
measure: Bodyweight (kg)
timeFrame: From inclusion to 4 and 56 weeks after discharge
measure: Quality of life
timeFrame: From inclusion to 56 weeks after discharge
measure: Medication under-prescribing
timeFrame: From inclusion to 4 weeks after discharge
measure: Inflammation in malnourished patients
timeFrame: 4 weeks after discharge
measure: Functional recovery score
timeFrame: From inclusion to 56 weeks after discharge
measure: Cystatin C
timeFrame: From inclusion to 56 weeks after discharge
measure: Cytokine concentrations
timeFrame: From inclusion to 56 weeks after discharge
measure: Cytometry
timeFrame: From inclusion to 56 weeks after discharge
measure: miRNA
timeFrame: From inclusion to 56 weeks after discharge
measure: NF-kB activation
timeFrame: From inclusion to 56 weeks after discharge
measure: C-reactive protein (inflammation)
timeFrame: From inclusion to 56 weeks after discharge
measure: Soluble urokinase plasminogen activator receptor (suPAR) (ng/ml)
timeFrame: From inclusion to 56 weeks after discharge
measure: Frequency of physicians' acceptance of suggested changes in medications
timeFrame: At inclusion and at 4 weeks after discharge in the FAM group
Other outcomes:
measure: Sit-to-stand test
timeFrame: From inclusion to 56 weeks after discharge
measure: Cognitive functional ability
timeFrame: From inclusion to 56 weeks after discharge
measure: Waist circumference (cm)
timeFrame: From inclusion to 56 weeks after discharge
measure: Handgrip strength (kg) of dominant hand
timeFrame: From inclusion to 56 weeks after discharge
measure: Habitual 4 m gait speed (m/s)
timeFrame: From inclusion to 56 weeks after discharge
measure: Plasma and serum concentrations of admission blood samples
timeFrame: From inclusion to 56 weeks after discharge
measure: Blood concentration of cholesterol and triglycerides
timeFrame: From inclusion to 56 weeks after discharge
measure: Blood concentration of metabolic markers
timeFrame: From inclusion to 56 weeks after discharge
measure: Plasma concentration of active drug substances
timeFrame: From inclusion to 56 weeks after discharge
measure: CMV-IgG (Cytomegalovirus-immunoglobulin G)
timeFrame: From inclusion to 56 weeks after discharge
Locations:
city: Hvidovre
country: Denmark
facility: Amager & Hvidovre Hospital
state: Region Hovedstaden
Study officials:
affiliation: Hvidovre University Hospital
name: Ove Andersen, MD, PhD
role: STUDY_CHAIR
affiliation: Hvidovre University Hospital
name: Morten B. Houlind, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Juliette Tavenier, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Line JH Rasmussen, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Aino L Andersen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bornaes O, Andersen AL, Houlind MB, Kallemose T, Tavenier J, Aharaz A, Nielsen RL, Jorgensen LM, Beck AM, Andersen O, Petersen J, Pedersen MM. Mild Cognitive Impairment Is Associated with Poorer Nutritional Status on Hospital Admission and after Discharge in Acutely Hospitalized Older Patients. Geriatrics (Basel). 2022 Sep 10;7(5):95. doi: 10.3390/geriatrics7050095.