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

Shamir Medical Center (Assaf-Harofeh)

Status: Unknown

Conditions: Hemodialysis Nutritional Risk Stratification; Malnutrition-Inflammation Syndrome

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT01214447

132/10

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

300 participants in 3 patient groups

Low - OSND less than 22

Treatment:

Other: No intervention

Moderate - OSND score 23-27

Treatment:

Other: No intervention

Normal - OSND score 28-32

Treatment:

Other: No intervention