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

This study is currently recruiting participants.
Verified September 2010 by Assaf-Harofeh Medical Center
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01214447
First received: October 3, 2010
Last updated: October 4, 2010
Last verified: September 2010
History of Changes

October 3, 2010
October 4, 2010
October 2010
October 2013   (final data collection date for primary outcome measure)
All cause morbidity and mortality [ Time Frame: during 2 years of observation ] [ Designated as safety issue: No ]

  • 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.
Same as current
Complete list of historical versions of study NCT01214447 on ClinicalTrials.gov Archive Site
All cause morbidity and mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
Same as current
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Validity and Reproducibility of OSND (Objective Score of Nutrition on Dialysis) as a Nutritional Marker in End-stage Renal Disease
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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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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).
  • Malnutrition-Inflammation Syndrome
  • Hemodialysis Nutritional Risk Stratification
Other: No intervention
Observational study - no intervention
  • Low - OSND less than 22
    Intervention: Other: No intervention
  • Moderate - OSND score 23-27
    Intervention: Other: No intervention
  • Normal - OSND score 28-32
    Intervention: Other: No intervention
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. Epub 2010 Feb 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2013
October 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Ilia Beberashvili, MD +97289779383 iliab@asaf.health.gov.il
Israel
 
NCT01214447
132/10
Not Provided
Ilia Beberashvili MD, Nephrology Division, Assaf Harofeh Medical Center
Assaf-Harofeh Medical Center
Not Provided
Principal Investigator: Ilia Beberashvili, MD Nephrology division Assaf Harofeh Medical Center
Assaf-Harofeh Medical Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP