Nutrition Based Computerized Predictive Method for Morbidity & Mortality Risk in HD Patients. Assisng NIR for Blood Cr (Hemodialysis)

Development of a Risk Computerized Predictive Method in HD Patients by Nutritional Scoring & Assesment of NIR Method for Cr Determination

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. Patients who are at risk of malnutrition will be treated by a standard nutrition; dietary counseling (high protein diet, appropriate calories intake and use of oral supplementation. Intra-dialytic parenteral nutrition (IDPN) will be used for patients who fail to improve nutrition status by standard nutrition care, as a second line treatment. The effect of IDPN on their nutrition status will be evaluated. A sub group of 30 patients will provide blood smample to assess a NIR method for Cr determination as creatinine is one of the parameters our nutrition score is based on.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Mortality; Malnutrition; Morbidity

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).

A sub group of 30 patients will provide blood smample to assess a Near Infra Red (NIR) method for Cr determination. Application of chemometric approach will serve for constructing a fitting curve between tradtional CR measurment with NIR method.

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

Study Locations

• Israel
  • Holon, Israel
    • Recruiting
    • Wolfson Medical Center
    • Contact: Zvi Barnea, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients on hemodialysis, Wolfson Hospital

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: January 1, 2010
• First Submitted That Met QC Criteria: January 4, 2010
• First Posted (Estimate): January 5, 2010

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Inflammation; Malnutrition
• Other Study ID Numbers: 0074-09-WOMC