Asymptomatic Bacteriuria, Hyponatremia and Geri-atric Syndrome

NCT05055856 | Completed

• 1 other identifier: asymptomatische bacteriuria
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Asymptomatic Bacteriuria; Frailty; Geriatric Syndrome; SIADH

Outcome Measures

Primary Outcomes (3)

• asymptomatic bacteriuria

  If the presence of an asymptomatic bacteriuria is associated with frailty or the geriatric syn-drome

  At baseline

• SIADH

  If the presence of SIADH-related hyponatremia is associated with frailty or geriatric syn-drome

  At baseline

• 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).

  At baseline

Study Arms (2)

Frailty or more

ACTIVE COMPARATOR

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

Diagnostic Test: urine sample; Diagnostic Test: Blood and urine sample

healthy

PLACEBO COMPARATOR

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

Diagnostic Test: urine sample; Diagnostic Test: Blood and urine sample

Interventions

urine sample DIAGNOSTIC_TEST

Each participant will give a urine sample for diagnose of asymptomatic bacteriuria

Frailty or more; healthy

Blood and urine sample DIAGNOSTIC_TEST

Each participant will give a urine and blood sample for diagnose of SIADH

Frailty or more; healthy

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• Symptoms of urinary tract infection
• Confusion
• CRP \> 5 mg/L
• Previous urological history
• Intake of antibiotics
• Intake of diuretics
• Intake of SSRI

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (4)

• 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.

  PMID: 30287177 BACKGROUND

• 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.

  PMID: 11909686 BACKGROUND

• 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.

  PMID: 21196778 BACKGROUND

• 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.

  PMID: 16238023 BACKGROUND

MeSH Terms

Conditions

Frailty; Inappropriate ADH Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nathalie Compte, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: academic, prospective study

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 24, 2021
• Study Start: October 30, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)