NCT01042405

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

11.1 years

First QC Date

January 1, 2010

Last Update Submit

January 30, 2020

Conditions

MalnutritionInflammationMorbidityMortality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients on hemodialysis, Wolfson Hospital

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson Medical Center

Holon, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The samples were kept for additional NIR determination of Cr

MeSH Terms

Conditions

MalnutritionInflammation

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Zvi Barnea, MD

CONTACT

97235028287barnea@wmc.gov.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Nephrologist

Study Record Dates

First Submitted

January 1, 2010

First Posted

January 5, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2021

Study Completion

October 1, 2021

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

IL(1)