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Development of New Computerized Predictive Method for Morbidity and Mortality Risk in Hemodialysis (HD) Patients Based on Nutritional Evaluation and Scoring (HD- dialysis)

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ClinicalTrials.gov Identifier: NCT01042405
Recruitment Status : Unknown
Verified December 2009 by Wolfson Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : January 5, 2010
Last Update Posted : March 4, 2010
Sponsor:
Information provided by:
Wolfson Medical Center

Brief Summary:
The aim of the study is to develop a simple computer program, evaluating nutritional status of HD patients. The programming will enable to perform a nutritional screening, based on biochemical measures, taken as part of HD patients' routine care every month. The program will identify patients at risk of malnutrition, define the degree of malnutrition, and identify patients who at risk for increased morbidity and mortality.

Condition or disease
Malnutrition Inflammation Morbidity Mortality

Detailed Description:
30 patients will randomly be selected for SGA examination and comparison to the MARK results every month. Frequency and duration of hospitalizations within the 5-month collection period will documented, mortality will be documented as well. Effect of different nutritional supplementations or IDPN will be assessed. The MARK nutrition screening will be used for all patients at the beginning of every month. Monthly Biochemical data using a blood sample taken immediately before dialysis will be used to calculate a value between 0-100 showing patient's monthly nutritional status. Data for the SGA will be collected for the same dialysis patients randomly selected at the same month. The nutritional state of the patients according to the SGA will be assessed by two investigators. A statistical test will be held for agreement between observers (Cohen's k concordant coefficient).

Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Risk Computerized Predictive Method in HD Patients by Nutritional Scoring
Study Start Date : February 2010
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients on hemodialysis, Wolfson Hospital
Criteria

Inclusion Criteria:

  • All dialysis patients in Wolfson Medical Center dialysis unit above the age of 18 years and on dialysis more than 3 months.

Exclusion Criteria:

  • Patients with bilateral plegia. Hemiplegic organs of a patient (not the entire patient).

Responsible Party: Zvi Barnea M.D., Department of Nephrology
ClinicalTrials.gov Identifier: NCT01042405     History of Changes
Other Study ID Numbers: 0074-09-WOMC
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: March 4, 2010
Last Verified: December 2009

Additional relevant MeSH terms:
Inflammation
Malnutrition
Pathologic Processes
Nutrition Disorders