Estimate for Dietary Intakes and Hemodialysis Patients

Chronic Renal Failure Clinical Trial

— EDDEN  

Official title:

Evaluation of the Use of an Analog Scale to Estimate Dietary Intakes, EPA, for Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772171
• Other study ID #: 17-250
• Status: Completed
• Start date: October 30, 2018
• Est. completion date: December 10, 2021

Study information

• Verified date: February 2022
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Dialysis
• Dietetician
• Kidney Failure, Chronic
• Nutrition Disorders

Locations

Country	Name	City	State
France	Néphrology Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the validity of the EPA to estimate, on an outpatient basis, dietary intakes in dialysis patients	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).	10 days