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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03135717
Other study ID # 69HCL14-253
Secondary ID
Status Completed
Phase N/A
First received April 24, 2017
Last updated April 26, 2017
Start date December 2011
Est. completion date June 2012

Study information

Verified date April 2017
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group 44 Years to 73 Years
Eligibility Inclusion Criteria:

- Patients with kidney disease

- Patients hospitalized in a university hospital renal ward

Exclusion Criteria:

- Hospitalization less than two weeks

Study Design


Intervention

Dietary Supplement:
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)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Outcome

Type Measure Description Time frame Safety issue
Primary Nutritional care evaluated with questionnaire Since admissions to hospital, up to 4 weeks
Secondary body composition Since admissions to hospital, up to 4 weeks
Secondary physical activity Since admissions to hospital, up to 4 weeks