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

NCT ID: NCT01214447

Last Updated: 2010-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malnutrition-Inflammation Syndrome Hemodialysis Nutritional Risk Stratification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Low - OSND less than 22

No intervention

Intervention Type OTHER

Observational study - no intervention

Moderate - OSND score 23-27

No intervention

Intervention Type OTHER

Observational study - no intervention

Normal - OSND score 28-32

No intervention

Intervention Type OTHER

Observational study - no intervention

Interventions

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No intervention

Observational study - no intervention

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nephrology Division, Assaf Harofeh Medical Center

Principal Investigators

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Ilia Beberashvili, MD

Role: PRINCIPAL_INVESTIGATOR

Nephrology division Assaf Harofeh Medical Center

Locations

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Assaf Harofeh Medical Center

Ẕerifin, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ilia Beberashvili, MD

Role: CONTACT

[email protected]
+97289779383

References

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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.

Reference Type BACKGROUND
PMID: 20190238 (View on PubMed)

Other Identifiers

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132/10

Identifier Type: -

Identifier Source: org_study_id