Nutrition DisordersEDDENNCT03772171
Estimate for Dietary Intakes and Hemodialysis Patients
An observational study of Nutrition Disorders and Dialysis, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition Disorders, Dialysis, Chronic Renal Failure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2018to 10 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic end stage renal failure treated by hemodialysis in hemodialysis center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Use of an Analog Scale to Estimate Dietary Intakes, EPA, for Hemodialysis Patients
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.
- Conditions
- Nutrition Disorders, Dialysis, Chronic Renal Failure, Dietetician
- Medical subject headings
- Nutrition Disorders, Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start30 Oct 2018
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772171
- Sponsor's protocol ID
- 17-250
- Acronym
- EDDEN
- Status last verified
- Feb 2022
- First submitted
- 10 Dec 2018
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of an Analog Scale to Estimate Dietary Intakes, EPA, for Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03772171
- Acronym / sponsor ID
- EDDEN / 17-250
- Conditions
- Nutrition Disorders, Dialysis, Chronic Renal Failure, Dietetician
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic end stage renal failure treated by hemodialysis in hemodialysis center
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Disorders and Dialysis, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the validity of the EPA to estimate, on an outpatient basis, dietary intakes in dialysis patients (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.