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Asymptomatic Bacteriuria, Hyponatremia and Geri-atric Syndrome

Primary Purpose

Asymptomatic Bacteriuria, Frailty, Geriatric Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
urine sample
Blood and urine sample
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asymptomatic Bacteriuria

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UZ BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Frailty or more

healthy

Arm Description

patients with the geriatric syndrome who will be recruited at the geriatric out patient clinic

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

Outcomes

Primary Outcome Measures

asymptomatic bacteriuria
If the presence of an asymptomatic bacteriuria is associated with frailty or the geriatric syn-drome
SIADH
If the presence of SIADH-related hyponatremia is associated with frailty or geriatric syn-drome
SIADH and inflammaging
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).

Secondary Outcome Measures

Full Information

First Posted
September 14, 2021
Last Updated
January 30, 2023
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT05055856
Brief Title
Asymptomatic Bacteriuria, Hyponatremia and Geri-atric Syndrome
Official Title
Asymptomatic Bacteriuria, Hyponatremia and Geri-atric Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2021 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The population is aging. Aged people are more prown to develop frailty. The causes of frailty are multifactorial and are being investigated in research settings. Cardiovascular diseases, inflammaging and changes in microbiota have been associated with frailty and geriatric syndrome. The prevalence of asymptomatic bacteriuria and SIADH-related hyponatremia is also important in aging and associated with inflammaging. The aim of this study is to examine, if asymptomatic bacteriuria and SIADH-related hyponatremia could be markers for frailty and geriatric syndrome.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymptomatic Bacteriuria, Frailty, Geriatric Syndrome, SIADH

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
academic, prospective study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Frailty or more
Arm Type
Active Comparator
Arm Description
patients with the geriatric syndrome who will be recruited at the geriatric out patient clinic
Arm Title
healthy
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
urine sample
Intervention Description
Each participant will give a urine sample for diagnose of asymptomatic bacteriuria
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood and urine sample
Intervention Description
Each participant will give a urine and blood sample for diagnose of SIADH
Primary Outcome Measure Information:
Title
asymptomatic bacteriuria
Description
If the presence of an asymptomatic bacteriuria is associated with frailty or the geriatric syn-drome
Time Frame
At baseline
Title
SIADH
Description
If the presence of SIADH-related hyponatremia is associated with frailty or geriatric syn-drome
Time Frame
At baseline
Title
SIADH and inflammaging
Description
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).
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie compté, PhD
Phone
024749159
Ext
9159
Email
nath_compte@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bert Bravenboer, PhD
Phone
024749512
Ext
9512
Email
bert.Bravenboer@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Compte, PhD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Compté, PhD
Phone
024749159
Ext
9159
Email
nath_compte@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30287177
Citation
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.
Results Reference
background
PubMed Identifier
11909686
Citation
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.
Results Reference
background
PubMed Identifier
21196778
Citation
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.
Results Reference
background
PubMed Identifier
16238023
Citation
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.
Results Reference
background

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Asymptomatic Bacteriuria, Hyponatremia and Geri-atric Syndrome

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