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 (ATIICA)

November 6, 2023 updated by: Poitiers University Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 days maximum

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison comfort of patient between the 2 periods with VAS
Time Frame: 15 days maximum
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
15 days maximum
Compare between the 2 periods the rate of bladder catheterization during the study
Time Frame: 15 days maximum
15 days maximum
Compare the mortality rate between the 2 periods
Time Frame: 15 days maximum
15 days maximum
Compare the average length of stay of patients between the 2 periods
Time Frame: 15 days maximum
15 days maximum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Sophie PAJOUX, CHU de Poitiers FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2022

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATIICA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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