Recruiting NCT07501195

Methods for Nutrition, Inflammation, Kidney Function, Aging, Body Composition, and Hydration Among Older Patients

— Observational Malnutrition Elderly Kidney Diseases Dehydration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Malnutrition Elderly, Kidney Diseases, Dehydration. Basic parameters: from 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Denmark
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Methods for Assessing Nutrition, Inflammation, Kidney Function, Aging, Body Composition, and Hydration Among Older Patients - An Observational Study (MIKADO)

Overview

The goal of this observational study, is to improve the diagnostic assessment method of malnutrition and kidney diseases, amongst hospitalized and low priority patients, by evaluating modern methodology and biomarkers, with regards to an estimate of the nutritional status and kidney diseases, against current gold standards, and also investigate how body composition, hydration, inflammation and age affect the assessments.

Primary outcome measures

To investigate whether the method used to determine body composition affects the diagnosis of malnutrition when applying the GLIM criteria. [Time frame: Time of inclusion and/or 14 days after preliminary inclusion.]
To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS in acutely hospitalized patients with a cystatin C/kreatinin ratio <0,7 (patients from groups 1 and 2) [Time frame: From enrollment to 6-8 hours later same day (when mGFRDBS is completed)]
To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS in patients aged ≥90 år (patients from groups 1 and 3) [Time frame: From enrollment to 6-8 hours later same day (when mGFRDBS is completed)]
To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS in patients with BMI ≥35 kg/m2 (patients from groups 1 and 4) [Time frame: From enrollment to 6-8 hours later same day (when mGFRDBS is completed)]
To determine changes in mGFRDBS during and after treatment with ≥37.5 mg daily prednisolone (patients from group 5) [Time frame: From enrollment to approximately 10-35 days after prednisolone treatment]
To determine changes in mGFRDBS before and after amputation (patients from group 6) [Time frame: From enrollment to follow-up after amputation (approximately 3 weeks after operation)]

Secondary outcome measures (12)

To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS during and after treatment with ≥37.5 mg daily prednisolone (patients from group 5) [Time frame: From enrollment to approximately 10-35 days after prednisolone treatment]
To evaluate the performance of eGFR based on creatinine, cystatin C, B2M, and BTP relative to mGFRDBS before and after amputation (patients from group 6) [Time frame: From enrollment to follow-up after amputation (approximately 3 weeks after operation)]
To investigate the impact of body composition on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation) [Time frame: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)]
To investigate the impact of hydration status on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation) [Time frame: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)]
To investigate the impact of inflammatory and aging markers on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation) [Time frame: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)]
To investigate the impact of nutritional status on the performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to mGFRDBS (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation) [Time frame: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)]
To investigate the impact of performance of eGFR based on creatinine, cystatin C, B2M, and BTP in relation to dosing of renal risk medications (patients from group 1, 2, 3, 4, 5 (after prednisolone treatment), and 6 (before amputation) [Time frame: From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome)]
To investigate the prevalence of sarcopenia and sarcopenic obesity, and to characterize these groups. [Time frame: At inclusion and after 2 weeks]
To investigate whether the estimation of body composition is affected by patient dehydration [Time frame: 2 weeks after inclusion]
To investigate how differences between GFR estimates are affected by hydration [Time frame: At Inclusion and two weeks after]
To determine whether the use of medications with potential dehydrating effects can predict dehydration." [Time frame: Atr inclusion and two weeks after]
To investigate the prevalence of dehydration [Time frame: At inclusion and two weeks after]

Eligibility criteria

Inclusion criteria

65 years or older (group 1, 4 and 5)
90 years or older (group 3)
Acute admission (group 1, 2)
Cognitively able to cooperate (group 1)
Able to read and speak Danish (group 1, 2, 3, 4, 5, 6)
BMI ≥ 35 kg/m2 (group 4)
Prednisolon treatment for COPD (≥ 37,5 mg daily) (group 5)
Amputation(s) of crus or femur (non-traumatic) (group 6)

Exclusion criteria

Isolation (group 1, 2, 3, 4, 5, 6)
Terminal treatment (group 1, 2, 3, 4, 5, 6)
Suicidal (group 1, 2, 3, 4, 5, 6)
Active Immune suppressing treatment (group 2, 3, 4, 5, 6)
Oedemas (group 2, 3, 4, 5, 6)
In active treatment for cancer (group 2, 3, 4, 5, 6)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Denmark · 1 center

Hvidovre Hospital — Copenhagen

Identifiers

NCT: NCT07501195 · 89194

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗