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

NCT ID: NCT01042405

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2021-10-31

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. 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.

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.

Conditions

Malnutrition; Inflammation; Morbidity; Mortality

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wolfson Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zvi Barnea

Senior Nephrologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wolfson Medical Center

Holon, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Zvi Barnea, MD

Role: CONTACT

barnea@wmc.gov.il

97235028287

Facility Contacts

Zvi Barnea, MD

Role: primary

Other Identifiers

0074-09-WOMC

Identifier Type: -

Identifier Source: org_study_id