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Estimate for Dietary Intakes and Hemodialysis Patients (EDDEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772171
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

The aim of this clinical research is to evaluate the relevance of using the EPA slide to estimate dietary intakes in dialysis patients. The obtained results will be compared with the reference technique validated by the HAS: food intake over 3 days.

The aim is also to improve the global management of dialysis patients and improve their quality of life. The aim is to evaluate a quick and easy-to-use tool whose use has been demonstrated in hospitals but for which no study has been carried out in an ambulatory hospitalization context.


Condition or disease
Nutrition Disorders Dialysis Chronic Renal Failure Dietetician

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Use of an Analog Scale to Estimate Dietary Intakes, EPA, for Hemodialysis Patients
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : November 10, 2020
Estimated Study Completion Date : November 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis




Primary Outcome Measures :
  1. Evaluation of the validity of the EPA to estimate, on an outpatient basis, dietary intakes in dialysis patients [ Time Frame: 10 days ]
    The Gold Standard will calculate the energy intake of the patient from the food intake over 3 days, as a percentage of its energy needs, calculated according to the weight of the patient (actual weight if weight <30kg.m² and weight adjusted if weight ≥ 30kg.m²).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic end stage renal failure treated by hemodialysis in hemodialysis center
Criteria

Inclusion Criteria:

  • Patient must be able to understand and voluntarily sign an informed consent form
  • Patient with chronic end stage renal failure treated with hemodialysis.
  • Patient with age >= 18 years

Exclusion Criteria:

  • Patient treated by peritoneal dialysis
  • Patient with age < 18 years
  • Patient with intellectual limitations that may limit the comprehension of questionnaires
  • Patient with communication disorders or verbal comprehension
  • Patient not French speaking
  • Patient with enteral nutrition
  • Patient having been hospitalized for less than 2 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772171


Contacts
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Contact: Laura BRIEN, Dietetician +33231063023 brien-l@chu-caen.fr

Locations
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France
Néphrology Caen University Hospital Recruiting
Caen, France, 14000
Contact: Sonia GUILLOUET, health executive         
Sponsors and Collaborators
University Hospital, Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03772171    
Other Study ID Numbers: 17-250
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Nutrition Disorders
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic