Influence of Nutritional and Inflammational Status on Survival of Hemodialysis Patients

• Conditions: Inflammation; Body Composition

• Registration Number: NCT00410137
• Lead Sponsor: Assaf-Harofeh Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Status Verified: 2006-12
• Study First Submitted: 2006-12-10
• Study First Submitted QC: 2006-12-11
• Last Update Submitted: 2006-12-11
• Study First Posted: 2006-12-12
• Last Update Posted: 2006-12-12
• Study Completion: 2008-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Assaf-Harofeh Medical Center; 🇮🇱 Zerifin, Israel