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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03052192
Other study ID # FAM-CPH-cohort
Secondary ID H-16038786AHH-20
Status Active, not recruiting
Phase
First received
Last updated
Start date November 2016
Est. completion date December 2019

Study information

Verified date October 2019
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 212
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 110 Years
Eligibility 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

Study Design


Locations

Country Name City State
Denmark Amager & Hvidovre Hospital Hvidovre Region Hovedstaden

Sponsors (4)

Lead Sponsor Collaborator
Hvidovre University Hospital Clinical Research Centre, Lundbeck Foundation, Region Hovedstaden

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Sit-to-stand test Development in physical performance From inclusion to 56 weeks after discharge
Other Cognitive functional ability Orientation memory concentration, mini mental state examination, Hopkins verbal learning test, trail making test, digit symbol substitution test From inclusion to 56 weeks after discharge
Other Waist circumference (cm) From inclusion to 56 weeks after discharge
Other Handgrip strength (kg) of dominant hand Development in physical performance From inclusion to 56 weeks after discharge
Other Habitual 4 m gait speed (m/s) Development in physical performance From inclusion to 56 weeks after discharge
Other Plasma and serum concentrations of admission blood samples Routinely analyzed physiological biomarkers measured in plasma and serum From inclusion to 56 weeks after discharge
Other Blood concentration of cholesterol and triglycerides From inclusion to 56 weeks after discharge
Other Blood concentration of metabolic markers Measurement of insulin, blood glucose, and HbA1c From inclusion to 56 weeks after discharge
Other Plasma concentration of active drug substances From inclusion to 56 weeks after discharge
Other CMV-IgG (Cytomegalovirus-immunoglobulin G) Cytomegalovirus IgG titer From inclusion to 56 weeks after discharge
Primary Eating validation scheme score Development in nutritional status and risk factors of malnutrition within the FAM group. From inclusion to 4 weeks after discharge
Primary MAI score (Medication Appropriateness Index) Difference in summed MAI-score per patient. MAI score between inclusion and first follow-up visit (FAM group) From inclusion to 4 weeks after discharge
Primary NF-kB (Nuclear Factor Kappa light chain enhancer og activated B cells) activity 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. From inclusion to 56 weeks after discharge
Primary Chronic inflammation Stability and discriminative ability of new model for chronic inflammation (Control group 2) From inclusion to 4 weeks after inclusion
Primary NLRP3 activity Difference in NLRP3 inflammasome activity between groups. From inclusion to 56 weeks after discharge
Secondary Bodyweight (kg) Development in bodyweight From inclusion to 4 and 56 weeks after discharge
Secondary Quality of life EQ-5D-5L(EuroQol-5Dimentions-5Llevels), mini geriatric depression score From inclusion to 56 weeks after discharge
Secondary Medication under-prescribing Assessment of underutilization Index (AOU) From inclusion to 4 weeks after discharge
Secondary Inflammation in malnourished patients Characterize the level of inflammation in malnourished patients 4 weeks after discharge
Secondary Functional recovery score Assessing activities of daily living to characterize development in physical performance From inclusion to 56 weeks after discharge
Secondary Cystatin C From inclusion to 56 weeks after discharge
Secondary Cytokine concentrations The concentration of cytokines at baseline and in response to stimulation will be measured From inclusion to 56 weeks after discharge
Secondary Cytometry Characterization of immune cell subsets From inclusion to 56 weeks after discharge
Secondary miRNA Levels of miRNA will be measured, and their association with NF-kB activity and biological ageing will be investigated. From inclusion to 56 weeks after discharge
Secondary NF-kB activation The activation of NF-kB in response to stimulation. From inclusion to 56 weeks after discharge
Secondary C-reactive protein (inflammation) Difference in inflammation between groups From inclusion to 56 weeks after discharge
Secondary Soluble urokinase plasminogen activator receptor (suPAR) (ng/ml) The plasma level of suPAR is a measure of inflammation and can be used to assess the difference in inflammation between groups From inclusion to 56 weeks after discharge
Secondary Frequency of physicians' acceptance of suggested changes in medications At inclusion and at 4 weeks after discharge in the FAM group
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