Influence of Nutritional and Inflammational Status on Survival of Hemodialysis Patients

Assaf-Harofeh Medical Center1 site in 1 country100 target enrollmentMarch 2006

ConditionsInflammation Body Composition

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Inflammation
Sponsor: Assaf-Harofeh Medical Center
Enrollment: 100
Locations: 1
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

April 2008

Last Updated

19 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Assaf-Harofeh Medical Center

Eligibility Criteria

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