Diuresis in Incontinent PatientsATIICANCT05186428
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
A study testing adult diaper in people with Diuresis in Incontinent Patients, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 to 100 years
- Conditions the study is for
- Diuresis in Incontinent Patients
- What is being tested?
- adult diaper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2022to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sophie PAJOUX contact
Fanny ABRIAT contact
France1 site, 1 recruiting
- Recruiting
CHU de Poitiers
Poitiers, 86021
Sophie PAJOUX, sophie.pajoux@chu-poitiers.fr
Fanny ABRIAT, fanny.abriat@chu-poitiers.fr
About this study
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.
- Conditions
- Diuresis in Incontinent Patients
- Being tested
- carrying out standard care, adult diaper
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carrying out standard careOther
The adaptation of the diuretic treatment will be made according to the possible diuresis records and the weighing of the patient every 2 days.
adult diaperOther
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
| Study group | Role | What they receive |
|---|---|---|
| The "before" period | Other | Not described Receives: Other: carrying out standard care |
| the "after" period | Experimental | Not described Receives: Other: adult diaper |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days maximum
Secondary outcomes (5)
Comparison comfort of patient between the 2 periods with VAS
Measured: 15 days maximum
Compare between the 2 periods the rate of skin complications related to the 2 diuresis assessment techniques,
Measured: 15 days maximum
Compare between the 2 periods the rate of bladder catheterization during the study
Measured: 15 days maximum
Compare the mortality rate between the 2 periods
Measured: 15 days maximum
Compare the average length of stay of patients between the 2 periods
Measured: 15 days maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start6 Apr 2022
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diuresis in Incontinent PatientsStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie PAJOUX, Principal investigator, CHU de Poitiers FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186428
- Sponsor's protocol ID
- ATIICA
- Acronym
- ATIICA
- Status last verified
- Nov 2023
- First submitted
- 3 Dec 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05186428
- Acronym / sponsor ID
- ATIICA / ATIICA
- Conditions
- Diuresis in Incontinent Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The "before" period | Other | Other: carrying out standard care |
| the "after" period | Experimental | Other: adult diaper |
Who may qualify
- Ages
- 75 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carrying out standard careThe adaptation of the diuretic treatment will be made according to the possible diuresis records and the weighing of the patient every 2 days. | Other | The "before" period |
| adult diaperthe diuresis which will be calculated by making the difference between the weight of the soiled protection weighed and the weight of the dry protection | Other | the "after" period |
Primary outcome
Comparison of the duration of intravenous diuretic treatment during 2 periods
Time frame: 15 days maximum
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
5 secondary outcomes
Comparison comfort of patient between the 2 periods with VAS
Time frame: 15 days maximum
Compare between the 2 periods the rate of skin complications related to the 2 diuresis assessment techniques,
Time frame: 15 days maximum
Compare between the 2 periods the rate of bladder catheterization during the study
Time frame: 15 days maximum
Compare the mortality rate between the 2 periods
Time frame: 15 days maximum
Compare the average length of stay of patients between the 2 periods
Time frame: 15 days maximum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie PAJOUX contact
Fanny ABRIAT contact
Sophie PAJOUX principal investigator
CHU de Poitiers FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adult diaper in people with Diuresis in Incontinent Patients, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie PAJOUX (sophie.pajoux@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the duration of intravenous diuretic treatment during 2 periods (time frame: 15 days maximum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.