- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05055856
Asymptomatic Bacteriuria, Hyponatremia and Geri-atric Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The demographic evolution represents a challenge for the general public health. The global population, especially in the developed countries, is aging. Aging is associated with a decrease of physio-logical functions leading to frailty. Frailty is an important concept in geriatric medicine: it is a biological syndrome of decreased reserve and resistance to stressors resulting from cumulative decline across multiple physiological systems (like osteopenia, sarcopenia, dysregulation of hypothalamic axis …). Factors that lead to frailty influence each other and can be self-perpetuating. Frailty is a geriatric syndrome but there are a lot of other geriatric syndrome such as falls, undernutrition,… When young people are sick, they present mostly more than one symptom who can be referred to one disease or one cause. In contrast, geriatric patients will present one symptom, such as confusion, fall, undernutrition,… which can be referred to multifactorial causes or diseases. This is the concept of geriatric syndrome.
Frailty or geriatric syndrome has been related to inflammaging. Inflammaging, characterized by an increase of circulating cytokines such as interleukin (IL)-6 and acute phase proteins, is a feature of immunosenescence. This process of immunosenescence is suggested to participate in the pathogene-ses of frailty and geriatric syndromes. The possible origins of inflammaging are multifactorial and controversies still exist: cardiovascular (CV) diseases, depression and chronic cytomegalovirus (CMV) infections are associated with this pro-inflammatory state. These comorbidities are highly prevalent in geriatric patients and could therefore contribute to the association between low-grade inflammation, frailty and geriatric syndromes.
The intestinal barrier and microbiota are associated with frailty and inflammaging. Multiple potential pathways exist through which the gut microbiota can provoke inflammaging (through TLR, stimulation of immune cells, translocation, endotoxines et cetera). In the same way of thinking, asymptomatic bacteriuria could also be responsible of inflammaging and frailty. The prevalence of asymptomatic bacteriuria is increased with aging and in patient with diabetes. It has also been shown to be associated with chronic inflammation (sTNFR and TNFα), increased WBCC and neutrophils. To our knowledge, it is unknown if asymptomatic bacteriuria is associated with frailty.
Hyponatremia is highly prevalent in hospitalized patients. SIADH-related hyponatremia represents 1/3 of the causes of hyponatremia. The incidence of SIADH related hyponatremia is believed to be higher in older people. It is associated with an increased risk of falls, confusion and mortality. The physiological balance between water and salt changes with aging. SIADH is classified as an euvo-lemic status; however, it is caused by an excess of water. The inappropriate secretion of vasopressin( ADH=anti-diuretic hormone) increases the expression of the aquaporins in the renal tubules. These aquaporines increase the reabsorption of water resulting in an altered ratio of reabsorption of water and Salt, leading to hyponatremia. SIADH-related hyponatremia is also associated with inflammation. IL-6 and IL-1β are able to stimulate the pituitary-hypothalamic axis to secrete vasopressin. SIADH related hyponatremia could be also a sign of inflammaging and related with frailty.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nathalie Compté, PhD
- Phone Number: 9159 024749159
- Email: nath_compte@hotmail.com
Study Locations
-
-
Brussel
-
Jette, Brussel, Belgium, 1090
- Recruiting
- UZ Brussel
-
Contact:
- Nathalie Compté, PhD
- Phone Number: 9159 024749159
- Email: nath_compte@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥ 70 years old
- Informed consent
- Presence of the geriatric syndrome (dementia, depression, frailty, dependence, fall, undernu-trition, incontinence…) or not in function of the group
Exclusion Criteria:
- Symptoms of urinary tract infection
- Confusion
- CRP > 5 mg/L
- Previous urological history
- Intake of antibiotics
- Intake of diuretics
- Intake of SSRI
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Frailty or more
patients with the geriatric syndrome who will be recruited at the geriatric out patient clinic
|
Each participant will give a urine sample for diagnose of asymptomatic bacteriuria
Each participant will give a urine and blood sample for diagnose of SIADH
|
PLACEBO_COMPARATOR: healthy
healthy aged people defined as in the modified SENIEUR protocol who will be recruited by an extern call thanks UZ Brussel website of thanks to staff's knowledge
|
Each participant will give a urine sample for diagnose of asymptomatic bacteriuria
Each participant will give a urine and blood sample for diagnose of SIADH
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
asymptomatic bacteriuria
Time Frame: At baseline
|
If the presence of an asymptomatic bacteriuria is associated with frailty or the geriatric syn-drome
|
At baseline
|
SIADH
Time Frame: At baseline
|
If the presence of SIADH-related hyponatremia is associated with frailty or geriatric syn-drome
|
At baseline
|
SIADH and inflammaging
Time Frame: At baseline
|
If the presence of SIADH-related hyponatremia is associated with a low grade chronic in-flammation as demonstrated by a raised c-reactive protein (CRP).
|
At baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nathalie Compte, PhD, Universitair Ziekenhuis Brussel
Publications and helpful links
General Publications
- Fulop T, Witkowski JM, Olivieri F, Larbi A. The integration of inflammaging in age-related diseases. Semin Immunol. 2018 Dec;40:17-35. doi: 10.1016/j.smim.2018.09.003. Epub 2018 Oct 2.
- Prio TK, Bruunsgaard H, Roge B, Pedersen BK. Asymptomatic bacteriuria in elderly humans is associated with increased levels of circulating TNF receptors and elevated numbers of neutrophils. Exp Gerontol. 2002 May;37(5):693-9. doi: 10.1016/s0531-5565(02)00002-5.
- Swart RM, Hoorn EJ, Betjes MG, Zietse R. Hyponatremia and inflammation: the emerging role of interleukin-6 in osmoregulation. Nephron Physiol. 2011;118(2):45-51. doi: 10.1159/000322238. Epub 2010 Dec 22.
- Bergsten G, Wullt B, Svanborg C. Escherichia coli, fimbriae, bacterial persistence and host response induction in the human urinary tract. Int J Med Microbiol. 2005 Oct;295(6-7):487-502. doi: 10.1016/j.ijmm.2005.07.008.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- asymptomatische bacteriuria
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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