Influence of Nutritional and Inflammational Status on Survival of Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00410137
Recruitment Status : Unknown
Verified December 2006 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : December 12, 2006
Last Update Posted : December 12, 2006
Information provided by:
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.

Condition or disease
Inflammation Body Composition

Study Type : Observational
Enrollment : 100 participants
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : March 2006
Study Completion Date : April 2008

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00410137

Assaf-Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Ilia Beberashvili, MD    +972577346133   
Principal Investigator: Ilia Beberashvili, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Principal Investigator: Ilia Beberashvili, MD Assaf-Harofeh Medical Center Identifier: NCT00410137     History of Changes
Other Study ID Numbers: 43/06
First Posted: December 12, 2006    Key Record Dates
Last Update Posted: December 12, 2006
Last Verified: December 2006

Additional relevant MeSH terms:
Pathologic Processes