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

• Conditions: Malnutrition-Inflammation Syndrome; Hemodialysis Nutritional Risk Stratification
• Interventions: Other: No intervention

• Registration Number: NCT01214447
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-10
• Study First Submitted: 2010-10-03
• Study First Submitted QC: 2010-10-04
• Last Update Submitted: 2010-10-04
• Study First Posted: 2010-10-05
• Last Update Posted: 2010-10-05
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low - OSND less than 22	No intervention	-
Moderate - OSND score 23-27	No intervention	-
Normal - OSND score 28-32	No intervention	-

Primary Outcome Measures

Name	Time	Method
All cause morbidity and mortality	during 2 years of observation	* 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.

Secondary Outcome Measures

Name	Time	Method
All cause morbidity and mortality	2 years	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

Trial Locations

Locations (1)

Assaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel