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

Assaf-Harofeh Medical Center300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Malnutrition-Inflammation Syndrome Hemodialysis Nutritional Risk Stratification

Interventions

No interventionOTHER

Observational study - no intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female, age \> 18 years, in chronic hemodialysis treatment at least 3 months 2. 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 3. Patients with normal hydration status (edema-free), with no neuroid-muscular diseases 4. Informed consent obtained before any trial-related activities Exclusion Criteria: 1. Patients with edema, pleural effusion or ascites at their initial assessment 2. Patients with active malignant disease or liver cirrhosis 3. Patients with neuroid-muscular diseases 4. Patients on chronic treatment with steroids on doses \> 10 mg/day Prednisone (or equivalent) 5. Patients treated with immunosuppressive agents 6. Patients suffering from * Acute vasculitis * Severe systemic infections * Heart failure (NYHA class III-IV)

Outcomes

Primary Outcomes

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.

Time frame: during 2 years of observation

Secondary Outcomes

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

Time frame: 2 years