ClinicalTrials.gg
Status unknownNCT05186428ATIICAUpdated Nov 7, 2023

Evaluation of a Non-invasive Urinary Collection Technique for the Adaptation of Diuretic Treatment in Incontinent Heart Failure Patient Over 75 Years of Age in the Acute Phase

An interventional study of carrying out standard care and adult diaper in Diuresis in Incontinent Patients, sponsored by Poitiers University Hospital. Status unknown at 1 site in France. Open to participants aged 75 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
75 Years to 100 Years
Sex
All
01

Study summary

Heart failure is a general disease affecting many organs and regulatory systems with a prevalence of 10% after 75 years of age, leading to significant hospitalization in the elderly. This generates a significant cost for our health system. The management of patients over 75 years of age in acute heart failure requires special monitoring of diuresis and weight. However, it is sometimes difficult to collect urine from incontinent elderly patients (not catheterized, habitually wearing protection) under intravenous diuretics. The evaluation of a non-invasive technique of urine collection for the adaptation of diuretic treatment in the incontinent patient with heart failure over 75 years of age in the acute phase seems to us to be interesting to conduct.

02

Conditions studied

  • Diuresis in Incontinent Patients
03

In context

Lead sponsor

Poitiers University Hospital is the lead sponsor of 314 studies on the registry; 62 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient over 75 years of age
  • Geriatric short-stay inpatient, geriatric/cardio medicine unit geriatrics
  • Incontinent patient with urinary protection
  • Patient with acute heart failure according to the diagnosis made by the doctors of unity
  • Patient treated with intravenous diuretic
  • Patient benefiting from a social security scheme or benefiting from it by a third party
  • Patient who gave their non-opposition to the study after clear information

Exclusion criteria

Exclusion Criteria:

  • Patient hospitalized in another unit of the geriatric division
  • Patient allergic to the protections provided
  • Patient carrying a bladder probe upon entry into the unit
  • Patient with a precarious non-perfusable venous capital
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Other
    The "before" period

    Other: carrying out standard care

  • Experimental
    the "after" period

    Other: adult diaper

Interventions

  • Othercarrying out standard care

    The adaptation of the diuretic treatment will be made according to the possible diuresis records and the weighing of the patient every 2 days.

  • Otheradult diaper

    the diuresis which will be calculated by making the difference between the weight of the soiled protection weighed and the weight of the dry protection

06

What researchers measure

Primary outcomes

  1. Comparison of the duration of intravenous diuretic treatment during 2 periods

    The duration of intravenous diuretic treatment in incontinent heart failure patients over 75 years old without urinary catheterization during 2 period (before and after) * Before" period with usual diuresis measurement * After" period with weighing of diapers

    Time frame: 15 days maximum

Secondary outcomes

  1. Comparison comfort of patient between the 2 periods with VAS

    Time frame: 15 days maximum

  2. Compare between the 2 periods the rate of skin complications related to the 2 diuresis assessment techniques,

    Time frame: 15 days maximum

  3. Compare between the 2 periods the rate of bladder catheterization during the study

    Time frame: 15 days maximum

  4. Compare the mortality rate between the 2 periods

    Time frame: 15 days maximum

  5. Compare the average length of stay of patients between the 2 periods

    Time frame: 15 days maximum

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2022 (actual). Primary completion is estimated for Nov 2024, 31 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 3, 2021
First posted
Jan 11, 2022
StartActual
Apr 6, 2022
Primary completionEst.
Nov 2024
CompletionEst.
Nov 2024
Last update
Nov 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05186428
Responsible party
Sponsor
First posted
Jan 11, 2022
Start date
Apr 6, 2022
Primary completion
Nov 2024 (estimated)
Completion
Nov 2024 (estimated)
Last update
Nov 7, 2023

Study contacts

Sophie PAJOUX
Contact
sophie.pajoux@chu-poitiers.fr
Fanny ABRIAT
Contact
fanny.abriat@chu-poitiers.fr
Sophie PAJOUX
principal investigator · CHU de Poitiers FRANCE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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