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Clinical Trials/NCT00410137
NCT00410137UnknownNot Applicable

Influence of Nutritional and Inflammational Status on Survival of Hemodialysis Patients

Assaf-Harofeh Medical Center1 site in 1 country100 target enrollmentStarted: March 2006Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Defined Population
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Other Gov

Study Sites (1)

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