Validity and Reproducibility of OSND (Objective Score of Nutrition on Dialysis) as a Nutritional Marker in End-stage Renal Disease

Study Overview
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Brief Summary
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This prospective observational study is planned to validate OSND against the prospective morbidity and mortality in chronic hemodialysis patients and to examine the hypothesis that OSND risk stratification of chronic HD patients is useful in predicting outcomes and better than its component alone or in diverse combinations. The investigators specific aim is to validate OSND in chronic HD patients by comparing it with conventional measures of nutritional state, including blood tests, anthropometry, MIS, GNRI, bioelectric impedance analysis and several measures of clinical outcome including prospective mortality and hospitalization.

Conditions
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Malnutrition-Inflammation Syndrome, Hemodialysis Nutritional Risk Stratification

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age > 18 years, in chronic hemodialysis treatment at least 3 months Stable and adequate hemodialysis treatment three months prior to participation in study as defined by Kt/V > 1.2 and/or hemodialysis performed 4 hours 3 times weekly Patients with normal hydration status (edema-free), with no neuroid-muscular diseases Informed consent obtained before any trial-related activities Exclusion Criteria: Patients with edema, pleural effusion or ascites at their initial assessment Patients with active malignant disease or liver cirrhosis Patients with neuroid-muscular diseases Patients on chronic treatment with steroids on doses > 10 mg/day Prednisone (or equivalent) Patients treated with immunosuppressive agents Patients suffering from Acute vasculitis Severe systemic infections Heart failure (NYHA class III-IV)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low - OSND less than 22<br> | Other: No intervention<br>* Observational study - no intervention<br>|
| Moderate - OSND score 23-27<br> | Other: No intervention<br>* Observational study - no intervention<br>|
| Normal - OSND score 28-32<br> | Other: No intervention<br>* Observational study - no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause morbidity and mortality | Associations of OSND with: Morbidity: Days at hospital (over night stay). Measured from baseline to end of study Morbidity: Number of sick days during the study period Morbidity: Number of visits to health care professionals other than hospitals Mortality: From baseline visit to end of study Interobserver reproducibility of OSND. | during 2 years of observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause morbidity and mortality | Associations of MIS, GNRI and phase angle with: Morbidity: Days at hospital (over night stay). Measured from baseline to end of study Morbidity: Number of sick days during the study period Morbidity: Number of visits to health care professionals other than hospitals Mortality: From baseline visit to end of study | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Inflammation, Malnutrition, Phase Angle