Nutritional Status in Patients With Chronic Kidney Disease

September 25, 2025 updated by: Umeå University

Nutritional Status and Nutritional Problems in Patients With Chronic Kidney Disease Treated With Hemodialysis

The goal of this observational study is to investigate how the GLIM criteria* for the diagnosis of malnutrition should be operationalized in patients with chronic kidney disease (CKD) treated with hemodialysis. The main questions it aims to answer are:

  • How can malnutrition be defined when applying different combinations and operationalization strategies of the GLIM criteria?
  • How can information from other nutrition assessment tools be used in the operationalization of GLIM?

  • Which combinations and operationalization strategies of the GLIM criteria can best predict deterioration in quality of life, muscle strength, and increased mortality? An observational study on patients with CKD in hemodialysis will be performed. Variables will be extracted from the Swedish renal registry, SNR and medical records at two hemodialysis units at one university hospital in Sweden. With start in the fall of 2024, data will be collected during two timepoints (baseline and follow-up) when wanted variables for this study are routinely measured at the units.

    • The Global Leadership Initiative on Malnutrition (GLIM) criteria to diagnose malnutrition in adults

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Chronic Kidney Disease (CKD) treated with hemodialysis at one university hospital in Sweden.

Description

Inclusion Criteria:

  • age ≥18 years
  • dialysis duration >3 months prior to recruitment

Exclusion Criteria:

  • patients who only have a dialysis frequency of once a week
  • patients treated with a combination of peritoneal dialysis and hemodialysis or treated at home
  • patients were written consent cannot be obtained due to medical or mental illness or weakened state of health

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Malnutrition diagnosis
Time Frame: From Aug/Sept 2024 to May 2025
Malnutition diagnosis according to GLIM
From Aug/Sept 2024 to May 2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From Aug/Sept 2024 to Dec 28
Overall survival
From Aug/Sept 2024 to Dec 28
Muscle strength
Time Frame: From Aug/Sept 2024 to May 2025
Hand grip muscle strength
From Aug/Sept 2024 to May 2025
Health related quality of life
Time Frame: Aug/Sept 2024 (baseline)
Health related quality of life according to RAND36
Aug/Sept 2024 (baseline)
Muscle mass
Time Frame: From Aug/Sept 2024 to May 2025
Muscle mass according to Bioimpedance Spectroscopy and Calf circumference
From Aug/Sept 2024 to May 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

Uppsala University Hospital

Investigators

  • Principal Investigator: Sandra Einarsson, PhD, Umeå University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Estimated)

September 26, 2025

Last Update Submitted That Met QC Criteria

September 25, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-03363-01
  • 2022-06295 (Other Grant/Funding Number: The Swedish Research Council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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