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

NCT ID: NCT03052192

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 212 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-12-31

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.

Conditions

Aging; Polypharmacy; Malnutrition; Inflammation; Emergency Service, Hospital

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

FAM group (n=98)

≥65 years. Acutely admitted medical patients.

Included consecutively at admission to the Acute Medical Department at Amager and Hvidovre Hospital and Rigshospitalet - Glostrup.

Follow-up at 4 weeks and 56 weeks after discharge and at any readmissions in the study period.

Participants are interviewed on physical, mental and nutritional status, tested for functional and cognitive status, and have anthropometry, biochemistry, blood pressure, and immune activity measured. Participants are followed in national registries for information on diagnoses, hospital admissions, health care services used, and mortality.

If a patient uses ≥5 prescribed drugs before hospitalization, a medication review will be performed by a clinical pharmacist and a geriatrician.

Sample size calculations were performed for each primary outcome, and the final sample size was based on the calculation for the eating validation scheme which resulted in the largest sample size.

No interventions assigned to this group

Control group 1 (n=54)

≥65 years. No hospital admissions within the past two years.

Matched individually with patients in the FAM group by age, sex, and municipality.

Examined at inclusion and 52 weeks after inclusion.

Participants are interviewed on physical, mental and nutritional status, tested for functional and cognitive status, and have anthropometry, biochemistry, blood pressure, and immune activity measured. Participants are followed in national registries for information on diagnoses, hospital admissions, health care services used, and mortality.

No interventions assigned to this group

Control group 2 (n=60)

20-35 years 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.)

Examined at inclusion and 4 weeks after inclusion. The examination includes a questionnaire about life style, a physical examination, and blood samples.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• ≥65 years
• No hospital admissions within the past 2 years

• 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

• Unable to cooperate cognitively
• Terminal patients
• Patients in isolation

Control group 1:

• Acute admissions within the past 2 years
• Auto-immune diseases
• Treatment with immunosuppressive or biological therapies

Control group 2:

• Auto-immune or chronic diseases

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinical Research Centre

UNKNOWN

Sponsor Role: collaborator

Lundbeck Foundation

OTHER

Sponsor Role: collaborator

Region Hovedstadens Apotek

OTHER_GOV

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ove Andersen

Head of Clinical Research Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ove Andersen, MD, PhD

Role: STUDY_CHAIR

Hvidovre University Hospital

Morten B. Houlind, MSc

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Juliette Tavenier, MSc

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Line JH Rasmussen, MSc

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Aino L Andersen, MSc

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

Amager & Hvidovre Hospital

Hvidovre, Capital Region, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 36136804 (View on PubMed)

Other Identifiers

H-16038786

Identifier Type: OTHER

Identifier Source: secondary_id

AHH-2016-067 (I-suite 04931)

Identifier Type: OTHER

Identifier Source: secondary_id

FAM-CPH-cohort

Identifier Type: -

Identifier Source: org_study_id