ATIICA: 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

Sponsor
Poitiers University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05186428
Collaborator
(none)
80
1
2
7.9
10.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: carrying out standard care
  • Other: adult diaper
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Apr 6, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: The "before" period

Other: carrying 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.

Experimental: the "after" period

Other: adult 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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Comparison comfort of patient between the 2 periods with VAS [15 days maximum]

  2. Compare between the 2 periods the rate of skin complications related to the 2 diuresis assessment techniques, [15 days maximum]

  3. Compare between the 2 periods the rate of bladder catheterization during the study [15 days maximum]

  4. Compare the mortality rate between the 2 periods [15 days maximum]

  5. Compare the average length of stay of patients between the 2 periods [15 days maximum]

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Poitiers Poitiers France 86021

Sponsors and Collaborators

  • Poitiers University Hospital

Investigators

  • Principal Investigator: Sophie PAJOUX, CHU de Poitiers FRANCE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT05186428
Other Study ID Numbers:
  • ATIICA
First Posted:
Jan 11, 2022
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2022