Nutritional Status in Patients With Chronic Kidney Disease

NCT06580093 | Active Not Recruiting

• 2 other identifiers: 2024-03363-012022-06295
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malnutrition

Keywords

Malnutrition; Muscle mass; GLIM; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Malnutrition diagnosis

  Malnutition diagnosis according to GLIM

  From Aug/Sept 2024 to May 2025

Secondary Outcomes (4)

• Muscle mass

  From Aug/Sept 2024 to May 2025

• Overall survival

  From Aug/Sept 2024 to Dec 28

• Muscle strength

  From Aug/Sept 2024 to May 2025

• Health related quality of life

  Aug/Sept 2024 (baseline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Uppsala University hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Malnutrition; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra Einarsson, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

SE (1)