Study design Observational prospective study
The subjects Number of subjects 200 subjects: Average value CRP: group 1: 55; group 2: 84
Average standard deviation: 70.52 Power 80%: 158 deelnemers Power 90%: 202 deelnemers
alpha = 0.05 2-sample T-test.
Inclusion criteria
Acute inflammation is defined as a CRP ≥ 10 mg/l. We will include 2 groups of
participants:
Exclusion criteria Immunosuppressive therapy (NSAIDs, corticosteroids, chemotherapy,
immunotherapy), active cancer, antibiotics before admission, hematological diseases
Replacement of subjects None.
Restrictions and prohibitions for the subjects None.
Procedures
A) Questionnaires:
taken at UZ Brussels
Social: age, home, sex, marital status.
Clinical: smoking and alcohol habits, streptococcus pneumoniae and influenza
vaccination status, allergies, BMI, medical history, current treatment, reason for
current hospitalization.
Comprehensive geriatric assessment:
CIRS-G (Cumulative Illness Rating Score): to quantify disease burden. It rates each
organ system on a scale of 0 to 4, and differentiates older adults with the highest
risk of and severity of infection, from those with lower infection risk. 20
Katz scale (ADL: assessment of activities of daily living): It rates 6 tasks of
daily living (bathing, dressing, toilet, transfer, continence and eating) on a scale
from 1 to 4. A low score means absence of dependence, and a high score the maximum
of dependence for the task. 21
MMSE (Mini Mental Status Examination): a 0-30 score of cognitive functions, <24/30
meaning cognitive function impairment. 22 Patients with dementia:the investigators
will request approval to be included in the study to the family of the patients.
MUST (Malnutrition Universal Screening Tool): to assess nutritional status. It
divides patients into 3 groups: A low risk of malnutrition (score 0). A medium risk
of malnutrition (score 1): then it is recommended to observe the patient for dietary
intake. A high risk of malnutrition (score ≥2): treat the malnutrition. 23
Questionnaire for periodontal health. The newly developed questionnaire produces a
reliable assessment of the individual risk of periodontitis (total score) and the
need for periodontal treatment as well as the differentiation between gingivits and
peridontitis. 24
Grip strength: Inflammatory states in the elderly are also associated with a
decrease in muscle strength and fatigue resistance, as seen at UZ Brussels by
Bautmans et al. The reduced strength and fatigue resistance in geriatric patients
with inflammation are significantly related with the concentration of circulating
CRP levels. 25 In the study, the investigators will use the martin vigorimeter which
is at our disposal at the geriatrics ward of UZ Brussels, to measure the patients'
grip strength and muscle fatiguability and determine which factors seem to
contribute to a decrease in muscle strength (CRP, CVD, CVR, infection,
periodontitis, CMV status, onychomycosis, age). the investigators will use the
Martin vigorimeter (Elmed, Addison, IL) to assess grip strength and fatiguibility.
The investigators will ask the patients to squeeze the rubber bulb of the
vigorimeter as hard as possible in 3 consecutive attempts, to assess their grip
strength. The highest score for each hand is recorded. Fatigue resistance will be
assessed by asking the patient to squeeze the bulb of the vigorimeter as hard as
possible and to maintain this pressure as long as possible; the time (seconds) until
the pressure diminished to half of the maximal grip strength is recorded for each
hand.25 26 B) Collection of data from physical examination C) Clinical evaluation of
onychomycosis of the toenails: the investigators will perform a clinical examination
of the toenails. Following parameters are found to be significantly related to
positive mycology results in onychomycosis patients 8: scaling on one or both soles,
white crumbly patches on the nail surface, and an abnormal colour of the nail.
D) Follow up of bacterial and viral culture analyses
Observational data from bacterial and viral samples during hospitatalization :
Viral infection confirmed by nasopharynx swab for: influenza, RSV, parainfluenza,
rhinovirusses, coronaviruses
Bacterial infection confirmed with positive blood culture, positive articular
punction, positive expectorations, pneumonia on chest radiograph, or infection
documented by abdominal imagery (CT or echo), a positive urine culture with a
confirmed pyelonephritis with a renal echography or a DMSA scintigraphy or specific
clinical symptoms for pyelonephritis and positive hemoculture. A positive urine
culture alone is not considered as urine infection because of the high prevalence of
asymptomatic bacteriuria in geriatric patients.
E) Follow up of blood analyses:
Observational data from blood samples during hospitalization:
Day 0 (at the emergency department): CRP, total and differential WBCC, renal
function
Day 1: at hospitalization, within 24h of admission
Geriatric patients: CRP, total and differential WBCC, renal function, hepatic
function (transaminases), albumin, prealbumin, protein profile and monoclonal
protein, vitamin B12, folic acid, hemoglobin, hematocrit, TSH, CMV-serology.
Young patients: CRP, total and differential WBCC, renal function, albumin, vitamin
B12, folic acid, TSH, CMV-serology.
Day 3: CRP, total and differential WBCC.
Day 5: CRP, total and differential WBCC.
Flowchart Questionnaires, blood samples: conducted by Hanne Maes. Supervising MD: Dr.
Nathalie Compté, UZ Brussels.
Randomisation/blinding Observational study, not applicable.
Prior and concomitant therapy All medication can be continued during this study.
Study analysis Statistical analysis the investigators will perform student t-tests or
Mann-Whitney rank sum tests to compare geriatric/young patients with and without
infection. To assess the contribution of age, comorbidities and geriatric syndrome in the
kinetics of WBCC, the investigators will perform univariate and multivariate analyses.