Back to resultsEvaluation 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 (ATIICA)
Primary Purpose
Diuresis in Incontinent Patients
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
carrying out standard care
adult diaper
Sponsored by
About this trial
This is an interventional supportive care trial for Diuresis in Incontinent Patients
Eligibility Criteria
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:
- 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
Sites / Locations
- CHU de PoitiersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
The "before" period
the "after" period
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Comparison comfort of patient between the 2 periods with VAS
Compare between the 2 periods the rate of skin complications related to the 2 diuresis assessment techniques,
Compare between the 2 periods the rate of bladder catheterization during the study
Compare the mortality rate between the 2 periods
Compare the average length of stay of patients between the 2 periods
Full Information
NCT ID
NCT05186428
First Posted
December 3, 2021
Last Updated
July 19, 2023
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05186428
Brief 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
Acronym
ATIICA
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diuresis in Incontinent Patients
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The "before" period
Arm Type
Other
Arm Title
the "after" period
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
carrying out standard care
Intervention Description
The adaptation of the diuretic treatment will be made according to the possible diuresis records and the weighing of the patient every 2 days.
Intervention Type
Other
Intervention Name(s)
adult diaper
Intervention Description
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
Primary Outcome Measure Information:
Title
Comparison of the duration of intravenous diuretic treatment during 2 periods
Description
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 Outcome Measure Information:
Title
Comparison comfort of patient between the 2 periods with VAS
Time Frame
15 days maximum
Title
Compare between the 2 periods the rate of skin complications related to the 2 diuresis assessment techniques,
Time Frame
15 days maximum
Title
Compare between the 2 periods the rate of bladder catheterization during the study
Time Frame
15 days maximum
Title
Compare the mortality rate between the 2 periods
Time Frame
15 days maximum
Title
Compare the average length of stay of patients between the 2 periods
Time Frame
15 days maximum
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie PAJOUX
Email
sophie.pajoux@chu-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fanny ABRIAT
Email
fanny.abriat@chu-poitiers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie PAJOUX
Organizational Affiliation
CHU de Poitiers FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie PAJOUX
Email
sophie.pajoux@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Fanny ABRIAT
Email
fanny.abriat@chu-poitiers.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
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