NCT06580093

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started Aug 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Aug 2024Dec 2027

Study Start

First participant enrolled

August 21, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

August 28, 2024

Last Update Submit

September 25, 2025

Conditions

Keywords

MalnutritionMuscle massGLIM

Outcome Measures

Primary Outcomes (1)

  • Malnutrition diagnosis

    Malnutition diagnosis according to GLIM

    From Aug/Sept 2024 to May 2025

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 \>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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

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)

June 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

September 26, 2025

Record last verified: 2025-09

Locations