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

NCT01214447 | Unknown

• 1 other identifier: 132/10
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition-Inflammation Syndrome; Hemodialysis Nutritional Risk Stratification

Keywords

Hemodialysis; Inflammation; Malnutrition; Phase Angle

Outcome Measures

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.

  during 2 years of observation

Secondary Outcomes (1)

• All cause morbidity and mortality

  2 years

Study Arms (3)

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

No intervention OTHER

Observational study - no intervention

Low - OSND less than 22; Moderate - OSND score 23-27; Normal - OSND score 28-32

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 20190238 BACKGROUND

MeSH Terms

Conditions

Inflammation; Malnutrition

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Ilia Beberashvili, MD

  Nephrology division Assaf Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilia Beberashvili, MD

CONTACT

+97289779383; iliab@asaf.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 3, 2010
• First Posted: October 5, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 5, 2010

Record last verified: 2010-09

Locations

IL (1)