Dehydration, Kidney Diseases, Malnutrition Elderly
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Ove Andersen
Hvidovre University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To investigate whether the method used to determine body composition affects the diagnosis of malnutrition when applying the GLIM criteria. | Time of inclusion and/or 14 days after preliminary inclusion. | This will be conducted via BIA- and DXA-scans and with the use of GLIM criteria |
| 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) | From enrollment to 6-8 hours later same day (when mGFRDBS is completed) | mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis |
| 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) | From enrollment to 6-8 hours later same day (when mGFRDBS is completed) | mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis |
| 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) | From enrollment to 6-8 hours later same day (when mGFRDBS is completed) | mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis |
| To determine changes in mGFRDBS during and after treatment with ≥37.5 mg daily prednisolone (patients from group 5) | From enrollment to approximately 10-35 days after prednisolone treatment | mGFRDBS will be performed twice |
| To determine changes in mGFRDBS before and after amputation (patients from group 6) | From enrollment to follow-up after amputation (approximately 3 weeks after operation) | mGFRDBS will be performed twice |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | From enrollment to approximately 10-35 days after prednisolone treatment | mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis |
| 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) | From enrollment to follow-up after amputation (approximately 3 weeks after operation) | mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis |
| 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) | From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome) | BIA/DEXA |
| 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) | From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome) | mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis. Plasma osmolality is used as estimate of hydration status. |
| 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) | 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) | From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome) | 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 |
| 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) | From enrollment to approximately 10-35 days after prednisolone treatment (this assessment provides the last data for this outcome) | 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 |
| To investigate the prevalence of sarcopenia and sarcopenic obesity, and to characterize these groups. | At inclusion and after 2 weeks | 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) |
| To investigate whether the estimation of body composition is affected by patient dehydration | 2 weeks after inclusion | DXA/BIA scans, osmolarity estimations (Plasma Natrium, potassium, glucose, urea), |
| To investigate how differences between GFR estimates are affected by hydration | At Inclusion and two weeks after | Estimated osmolarity (Plasma Natrium, potassium, glucose, urea), estimated GFR |
| To determine whether the use of medications with potential dehydrating effects can predict dehydration." | Atr inclusion and two weeks after | Medication use, osmolarity estimation |
| To investigate the prevalence of dehydration | At inclusion and two weeks after | Estimated osmolarity |
| 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. | At inclusion and two weeks after | 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." |
| To identify potential biomarkers (including inflammatory and aging biomarkers) that may be associated with dehydration | At inclusion and two weeks after | 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. |
| To investigate differences in body composition during and after hospitalization for the patients included in sub-study 2A. | At inclusion and two weeks after | BIA/DXA |
| To characterize biomarker levels for inflammation, metabolism, aging and tissue damage in patients aged ≥90 år (patients from groups 1 and 3) | Enrollment | Biomarkers will be analyzed afterwards from the blood biobank |
| To investigate whether the estimation of body composition is affected by physical activity/rest." | 2 weeks after inclusion | DXA/BIA scans, 400 m walking distance and 15 mins rest |
| To characterize biomarker levels for inflammation, metabolism, aging and tissue damage in patients with BMI ≥35 kg/m2 (patients from groups 1 and 4) | Enrollment | Biomarkers will be analyzed afterwards from the blood biobank |
| To investigate whether the estimation of body composition is affected by fasting | 2 weeks after inclusion | DXA/BIA scans, 24 hours fasting and a light testmeal |
Countries
Denmark
Contacts
CONTACTOve OA Andersen, Professor
CONTACTRikke Lundsgaard Nielsen, Phd
PRINCIPAL_INVESTIGATOROve Andersen, Professor
Department of clinical research, Copenhagen University Hospital
Outcome results
None listed