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Influence of Nutritional and Inflammational Status on Survival of Hemodialysis Patients

NCT ID: NCT00410137

Last Updated: 2006-12-12

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-04-30

Brief Summary

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prospective longitudinal measurements of nutritional status parameters (body composition by BIA, anthropometry and biochemical indexes), inflammatory response (CRP, inflammatory cytokines (IL-1, IL-6, IL-10),IGF-1, leptin and NOx blood levels) and morbidity and mortality data collection over 2 year period in patients receiving chronic hemodialysis.

Detailed Description

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Conditions

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Inflammation Body Composition

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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 neuro-muscular diseases
* Informed consent obtained before any trial-related activities

Exclusion Criteria

* Patients with edema, pleural effusion or ascites at their initial assessment
* Patients with active malignant disease or liver cirrhosis
* Patients with neuro-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)
* The receipt of any investigational drug within 1 month prior to initiating of this study
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

Principal Investigators

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Ilia Beberashvili, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Locations

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Assaf-Harofeh Medical Center

Ẕerifin, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Ilia Beberashvili, MD

Role: primary

Other Identifiers

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43/06

Identifier Type: -

Identifier Source: org_study_id