Influence of Nutritional and Inflammational Status on Survival of Hemodialysis Patients

Inflammation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00410137
• Other study ID #: 43/06
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2006
• Last updated: December 11, 2006
• Start date: March 2006
• Est. completion date: April 2008

Study information

• Verified date: December 2006
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Body Composition
• Inflammation

Locations

Country	Name	City	State
Israel	Assaf-Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel,