Nutritional Status in Patients With Chronic Kidney Disease

Recruiting

• Conditions: Malnutrition

• Registration Number: NCT06580093
• Lead Sponsor: Umeå University

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? 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-21
• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-08-28
• Last Update Submitted: 2024-08-28
• Study First Posted: 2024-08-30
• Last Update Posted: 2024-08-30
• Primary Completion: 2026-06
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Malnutrition diagnosis	From Aug/Sept 2024 to May 2025	Malnutition diagnosis according to GLIM

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Uppsala University hospital; 🇸🇪 Uppsala, Sweden