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Clinical Trials/NCT06580093
NCT06580093
Active, not recruiting
Not Applicable

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

Umeå University1 site in 1 country69 target enrollmentAugust 21, 2024
ConditionsMalnutrition

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malnutrition
Sponsor
Umeå University
Enrollment
69
Locations
1
Primary Endpoint
Malnutrition diagnosis
Status
Active, not recruiting
Last Updated
7 months ago

Overview

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
Registry
clinicaltrials.gov
Start Date
August 21, 2024
End Date
December 1, 2027
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Malnutrition diagnosis

Time Frame: From Aug/Sept 2024 to May 2025

Malnutition diagnosis according to GLIM

Secondary Outcomes

  • 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))
  • Muscle mass(From Aug/Sept 2024 to May 2025)

Study Sites (1)

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