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.
Study Type
OBSERVATIONAL
Enrollment
500
Hvidovre Hospital
Copenhagen, Denmark
RECRUITINGTo investigate whether the method used to determine body composition affects the diagnosis of malnutrition when applying the GLIM criteria.
This will be conducted via BIA- and DXA-scans and with the use of 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)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
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)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
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)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
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)
mGFRDBS will be performed twice
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)
mGFRDBS will be performed twice
Time frame: From enrollment to follow-up after amputation (approximately 3 weeks after operation)
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)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
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)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis
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)
BIA/DEXA
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)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis. Plasma osmolality is used as estimate of hydration status.
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)
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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)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis. For nutritional status, metrics like SNAQ, MNA, GLIM, and NRS-2002
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)
mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis. Renal risk medications are identified and assessed for dosing agreement across eGFR in relation to mGFRDBS
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.
Assessed with Nutritonal status (NRS-2022, GLIM, MNA, SNAQ), bodycomposition with BIA/DXA, inflammatory biomarkers (such as GDF15), muscle function (HGS), physical performance (4 m gaitspeed) hydration (Plasma Natrium, potassium, glucose, urea)
Time frame: At inclusion and after 2 weeks
To investigate whether the estimation of body composition is affected by patient dehydration
DXA/BIA scans, osmolarity estimations (Plasma Natrium, potassium, glucose, urea),
Time frame: 2 weeks after inclusion
To investigate how differences between GFR estimates are affected by hydration
Estimated osmolarity (Plasma Natrium, potassium, glucose, urea), estimated GFR
Time frame: At Inclusion and two weeks after
To determine whether the use of medications with potential dehydrating effects can predict dehydration."
Medication use, osmolarity estimation
Time frame: Atr inclusion and two weeks after
To investigate the prevalence of dehydration
Estimated osmolarity
Time frame: At inclusion and two weeks after
To test and identify potential biomarkers, both individually and in a panel of multiple biomarkers (including inflammatory and aging biomarkers), that may be associated with or identify undernutrition and the risk of undernutrition.
Cytokines, growth factors, and other proteins measured by immunoassays (e.g., ELISA, PEA technology \[Olink, Organ Damage (n=92) and Inflammation (n=92) panels\]), including GDF15, FGF21, suPAR, IL-1β, IL-6, IL-10, TNF-α. Biological aging assessed by DNA methylation."
Time frame: At inclusion and two weeks after
To identify potential biomarkers (including inflammatory and aging biomarkers) that may be associated with dehydration
Cytokines, growth factors, and other proteins measured by immunoassays (e.g., ELISA, PEA technology \[Olink, organ damage (n=92) and inflammation (n=92) panels\]), including GDF15, FGF21, suPAR, IL-1β, IL-6, IL-10, and TNF-α. Biological aging assessed by DNA methylation.
Time frame: At inclusion and two weeks after
To investigate differences in body composition during and after hospitalization for the patients included in sub-study 2A.
BIA/DXA
Time frame: At inclusion and two weeks after
To characterize biomarker levels for inflammation, metabolism, aging and tissue damage in patients aged ≥90 år (patients from groups 1 and 3)
Biomarkers will be analyzed afterwards from the blood biobank
Time frame: Enrollment
To investigate whether the estimation of body composition is affected by physical activity/rest."
DXA/BIA scans, 400 m walking distance and 15 mins rest
Time frame: 2 weeks after inclusion
To characterize biomarker levels for inflammation, metabolism, aging and tissue damage in patients with BMI ≥35 kg/m2 (patients from groups 1 and 4)
Biomarkers will be analyzed afterwards from the blood biobank
Time frame: Enrollment
To investigate whether the estimation of body composition is affected by fasting
DXA/BIA scans, 24 hours fasting and a light testmeal
Time frame: 2 weeks after inclusion