Nutritional Status in Patients With Chronic Kidney Disease

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? This is an observational study on patients with CKD in hemodialysis. Variables are extracted from the Swedish renal registry, SNR and medical records at two hemodialysis units at one university hospital in Sweden. Data collection started in the fall of 2024, and are collected during two timepoints (baseline and follow-up) when wanted variables for this study are routinely measured at the units. Data on 2-year overall survival are also collected.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Malnutrition

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden
    • Uppsala University Hospital

Participation Criteria

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 more than 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Uppsala University Hospital
• Investigators: Principal Investigator: Sandra Einarsson, PhD, Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

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 (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: chronic kidney disease; Malnutrition; Muscle mass; GLIM
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Malnutrition; Renal Insufficiency, Chronic
• 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