Chronic Kidney HospitalizedPEWNCT03135717
Wasting in Chronic Kidney Disease
An observational study of Chronic Kidney Hospitalized, run by Hospices Civils de Lyon.
Trial summary
Protein energy wasting is an independent factor associated with morbi-mortality in chronic kidney disease. Wasting is particularly common in chronic diseases of organs such as kidney disease with a major impact at the stage of dialysis. Read more about this study
- Who is it for?
- Ages 44 to 73 years
- Conditions the study is for
- Chronic Kidney Hospitalized
- What is being tested?
- Nutritional care
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Jun 2012
- 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 44 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic kidney disease
Who may be able to join
- Patients with kidney disease
- Patients hospitalized in a university hospital renal ward
Who cannot join
- Hospitalization less than two weeks
About this study
Official title: Wasting in Chronic Kidney Disease: Refeeding Techniques and Artificial Nutrition Practices
Protein energy wasting is an independent factor associated with morbi-mortality in chronic kidney disease. Wasting is particularly common in chronic diseases of organs such as kidney disease with a major impact at the stage of dialysis. It covers 20 to 70% of patients diagnosed with chronic kidney disease according to the degree of evolution of the disease and the diagnostic method.
Mechanisms of PEW are based mainly on anorexia and metabolic abnormalities caused by kidney disease. Nutritional treatment differs depending on the stage of the kidney disease acute or chronic treated whether or not by dialysis. Nutritional monitoring should be regular, individualized and collaborative to detect a risk of PEW or treat installed PEW. Refeeding techniques should allow all the nutritional needs. Their indications depend on the clinic, biochemical assessment and nutrient intake.
- Conditions
- Chronic Kidney Hospitalized
- Being tested
- Nutritional care
- Keywords
- Chronic kidney disease, Enteral nutrition, Oral nutritional supplements, Parenteral nutrition, Refeeding, Wasting
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphagia, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional careDietary supplement
- Diagnosis of protein energy wasting : anthropometry, calculation of the nutrient intakes, evaluation of appetite, evaluation of gastrointestinal syndromes, hand grip test and bioimpedancemetry
- Treatment of protein energy wasting : estimation of nutritional requirements, prescription of oral nutritional supplement or artificial nutrition, physical rehabilitation
- Multidisciplinary approach (nephrologists, dieticians, physiotherapists, nurses)
- Evaluation of the nutritional treatment (plasma albumin and prealbumin, weight evolution, muscle strength and body composition)
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional care evaluated with questionnaire
Measured: Since admissions to hospital, up to 4 weeks
Secondary outcomes (2)
body composition
Measured: Since admissions to hospital, up to 4 weeks
physical activity
Measured: Since admissions to hospital, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study startDec 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney HospitalizedStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Fouque, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135717
- Sponsor's protocol ID
- 69HCL14-253
- Acronym
- PEW
- Status last verified
- Apr 2017
- First submitted
- 24 Apr 2017
- Last updated
- 1 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wasting in Chronic Kidney Disease: Refeeding Techniques and Artificial Nutrition Practices
- ClinicalTrials.gov ID
- NCT03135717
- Acronym / sponsor ID
- PEW / 69HCL14-253
- Conditions
- Chronic Kidney Hospitalized
- Keywords
- Chronic kidney disease, Enteral nutrition, Oral nutritional supplements, Parenteral nutrition, Refeeding, Wasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 May 2017 (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.
Protein energy wasting is an independent factor associated with morbi-mortality in chronic kidney disease. Wasting is particularly common in chronic diseases of organs such as kidney disease with a major impact at the stage of dialysis. It covers 20 to 70% of patients diagnosed with chronic kidney disease according to the degree of evolution of the disease and the diagnostic method.
Mechanisms of PEW are based mainly on anorexia and metabolic abnormalities caused by kidney disease. Nutritional treatment differs depending on the stage of the kidney disease acute or chronic treated whether or not by dialysis. Nutritional monitoring should be regular, individualized and collaborative to detect a risk of PEW or treat installed PEW. Refeeding techniques should allow all the nutritional needs. Their indications depend on the clinic, biochemical assessment and nutrient intake.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 44 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease
Key inclusion criteria (2 listed)
- Patients with kidney disease
- Patients hospitalized in a university hospital renal ward
Key exclusion criteria (1 listed)
- Hospitalization less than two weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional care* Diagnosis of protein energy wasting : anthropometry, calculation of the nutrient intakes, evaluation of appetite, evaluation of gastrointestinal syndromes, hand grip test and bioimpedancemetry * Treatment of protein energy wasting : estimation of nutritional requirements, prescription of oral nutritional supplement or artificial nutrition, physical rehabilitation * Multidisciplinary approach (nephrologists, dieticians, physiotherapists, nurses) * Evaluation of the nutritional treatment (plasma albumin and prealbumin, weight evolution, muscle strength and body composition) | Dietary supplement | – |
Primary outcome
Nutritional care evaluated with questionnaire
Time frame: Since admissions to hospital, up to 4 weeks
2 secondary outcomes
body composition
Time frame: Since admissions to hospital, up to 4 weeks
physical activity
Time frame: Since admissions to hospital, up to 4 weeks
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 1 May 2017.
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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.
Denis Fouque, Pr principal investigator
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Hospitalized, run by Hospices Civils de Lyon.
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 2 inclusion and 1 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 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Nutritional care evaluated with questionnaire (time frame: Since admissions to hospital, up to 4 weeks). 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 1 May 2017.