Influence of Nutritional and Inflammational Status on Survival of Hemodialysis Patients - Full Text View

Influence of Nutritional and Inflammational Status on Survival of Hemodialysis Patients

This study is currently recruiting participants.
Verified by Assaf-Harofeh Medical Center, December 2006

Sponsored by:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00410137

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

MedlinePlus related topics:

Dialysis Kidney Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Longitudinal, Defined Population, Prospective Study

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

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

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

Study placed in the following topic categories:

Inflammation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 15, 2008