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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01042405
First received: January 1, 2010
Last updated: March 3, 2010
Last verified: December 2009
  Purpose

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
Malnutrition
Inflammation
Morbidity
Mortality

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Risk Computerized Predictive Method in HD Patients by Nutritional Scoring

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Estimated Enrollment: 130
Study Start Date: February 2010
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Zvi Barnea M.D., Department of Nephrology
ClinicalTrials.gov Identifier: NCT01042405     History of Changes
Other Study ID Numbers: 0074-09-WOMC
Study First Received: January 1, 2010
Last Updated: March 3, 2010
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Inflammation
Malnutrition
Pathologic Processes
Nutrition Disorders

ClinicalTrials.gov processed this record on July 24, 2014