Clinical trial NCT01214447: Validity and Reproducibility of OSND (Objective Score of Nutrition on Dialysis) as a Nutritional Marker in End-stage Renal Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malnutrition-Inflammation Syndrome
Hemodialysis Nutritional Risk Stratification
Keywords: Hemodialysis
Inflammation
Malnutrition
Phase Angle
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-10-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 stable chronic hemodialysis patients receiving maintenance hemodialysis treatment in our dialysis unit (nephrology division, Assaf Harofeh Medical Center) and in 2 satellite hemodialysis units (Nephromor, Rishon Lezion and Afek, Ramla).

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.


Eligibility criteria: 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)

Primary outcomes:
measure: All cause morbidity and mortality
timeFrame: during 2 years of observation
Secondary outcomes:
measure: All cause morbidity and mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Nephrology division Assaf Harofeh Medical Center
name: Ilia Beberashvili, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beberashvili I, Azar A, Sinuani I, Yasur H, Feldman L, Averbukh Z, Weissgarten J. Objective Score of Nutrition on Dialysis (OSND) as an alternative for the malnutrition-inflammation score in assessment of nutritional risk of haemodialysis patients. Nephrol Dial Transplant. 2010 Aug;25(8):2662-71. doi: 10.1093/ndt/gfq031. Epub 2010 Feb 26.