Influence of Nutritional and Inflammational Status on Survival of Hemodialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00410137
First received: December 10, 2006
Last updated: December 11, 2006
Last verified: December 2006
  Purpose

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
Inflammation
Body Composition

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Estimated Enrollment: 100
Study Start Date: March 2006
Estimated Study Completion Date: April 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410137

Locations
Israel
Assaf-Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Ilia Beberashvili, MD    +972577346133    iliab@asaf.health.gov.il   
Principal Investigator: Ilia Beberashvili, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Ilia Beberashvili, MD Assaf-Harofeh Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00410137     History of Changes
Other Study ID Numbers: 43/06
Study First Received: December 10, 2006
Last Updated: December 11, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014