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Active, Not Recruiting

NCT Number: NCT06580093

Nutritional Status in Patients With Chronic Kidney Disease

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University hospital

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Malnutrition diagnosis

    Time frame: From Aug/Sept 2024 to May 2025

    Malnutition diagnosis according to GLIM

Secondary outcomes

  1. Muscle mass

    Time frame: From Aug/Sept 2024 to May 2025

    Muscle mass according to Bioimpedance Spectroscopy and Calf circumference

  2. Overall survival

    Time frame: From Aug/Sept 2024 to Dec 28

    Overall survival

  3. Muscle strength

    Time frame: From Aug/Sept 2024 to May 2025

    Hand grip muscle strength

  4. Health related quality of life

    Time frame: Aug/Sept 2024 (baseline)

    Health related quality of life according to RAND36

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Uppsala University Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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