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Status unknownNCT01214447Updated Oct 5, 2010

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

An observational study in Malnutrition-Inflammation Syndrome and Hemodialysis Nutritional Risk Stratification, sponsored by Assaf-Harofeh Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-05.

Sponsored by Assaf-Harofeh Medical Center · Observational

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Malnutrition-Inflammation Syndrome
  • Hemodialysis Nutritional Risk Stratification

Keywords

  • Hemodialysis
  • Inflammation
  • Malnutrition
  • Phase Angle
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In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's planned enrollment of 300 is above the median of 203 across 388 observational studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Assaf-Harofeh Medical Center is the lead sponsor of 258 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)

Groups and cohorts

  • Low - OSND less than 22

    Other: No intervention

  • Moderate - OSND score 23-27

    Other: No intervention

  • Normal - OSND score 28-32

    Other: No intervention

Interventions

  • OtherNo intervention

    Observational study - no intervention

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What researchers measure

Primary outcomes

  1. 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

  1. 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

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Study locations

1 of 1 sites recruiting
  • Assaf Harofeh Medical Center
    Zerifin, 70300, Israel
    • Ilia Beberashvili, MD · Principal investigator
    • Ada Azar, BSc · Sub investigator
    • Gregory Shapira, MD · Sub investigator
    • Inna Sinuani, PhD · Sub investigator
    Recruiting
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References and documents

Publications

  • 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. PubMed 20190238 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01214447
Lead sponsor
Assaf-Harofeh Medical Center
First posted
Oct 5, 2010
Start date
Oct 2010
Primary completion
Oct 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Oct 5, 2010

Study contacts

Ilia Beberashvili, MD
Contact
iliab@asaf.health.gov.il
+97289779383
Ilia Beberashvili, MD
principal investigator · Nephrology division Assaf Harofeh Medical Center
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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