Status:
UNKNOWN
Validity and Reproducibility of OSND (Objective Score of Nutrition on Dialysis) as a Nutritional Marker in End-stage Renal Disease
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Malnutrition-Inflammation Syndrome
Hemodialysis Nutritional Risk Stratification
Eligibility:
All Genders
18+ years
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 stratific...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01214447
Start Date
October 1 2010
End Date
December 1 2013
Last Update
October 5 2010
Active Locations (1)
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1
Assaf Harofeh Medical Center
Ẕerifin, Israel, 70300