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| Name | Class |
|---|---|
| Hvidovre University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Acutely admitted older medical patients (65 years old or above) | ||
| Group 2: | Acutely admitted medical patients, with a difference in eGFR, based on cystatin C and kreatinine of ≥ 30 %. | ||
| Group 3: | Hospitalized patients of 90 years or above. | ||
| Group 4: | Older hospitalized patients (65 years old or above), with a BMI ≥35 mg/m2. | ||
| Group 5: | Patients in active treatment with Prednisolon for COPD exacerbations. | ||
| Group 6: | Patiens who are undergoing a lower leg amputation. |
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| Measure | Description | Time Frame |
|---|---|---|
| To 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 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 | 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 | 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 | 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 | From enrollment to approximately 10-35 days after prednisolone treatment |
| To determine changes in mGFRDBS before and after amputation (patients from group 6) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to approximately 10-35 days after prednisolone treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Routine biochemistry | Standard bloodwork carried out by hospital staff during the patient's hospitalization.: ALAT, albumin, alkaline phosphatase, bilirubin, CO2, CRP, haemoglobin, INR, K+, blood urea nitrogen, coagulation factors, leucocytes, neutrophils, MCH, MCV, Na+, thrombocytes, lactate-dehydrogenases, NGAL, β-trace protein and β-trace microglobulins. | Time of inclusion, time of the mGFRDBS procedure, time of the BIA/DXA-scans or two weeks after the patient has been released from the hospital. |
Inclusion Criteria:
Exclusion Criteria:
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There are 6 patient groups in this study:
Group 1:
Elderly, 65 years old or above, acutely admitted medical patients.
Group 2:
Acutely admitted medical patients, with a difference in eGFR, based on cystatin C and kreatinine of ≥ 30 %.
Group 3:
Hospitalized patients of 90 years or above.
Group 4:
Elderly (≥65 år), hospitalized patients, with a BMI ≥35 mg/m2.
Group 5:
Patients in active treatment with Prednisolon for COPD exacerbations.
Group 6:
Patiens who are undergoing a lower leg amputation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ove OA Andersen, Professor | Contact | 004538626719 | ove.andersen@regionh.dk | |
| Rikke Lundsgaard Nielsen, Phd | Contact | ove.andersen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Ove Andersen, Professor | Department of clinical research, Copenhagen University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre Hospital | Recruiting | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Whole blood, plasma, serum, buffy coat.
mGFRDBS will be performed twice |
| 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 before and after amputation (patients from group 6) | mGFRDBS will be performed and the biomarkers will be analyzed afterwards for making this analysis | 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 | 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. | 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) | 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) | 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 | 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 | 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) | 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), | 2 weeks after inclusion |
| To investigate how differences between GFR estimates are affected by hydration | Estimated osmolarity (Plasma Natrium, potassium, glucose, urea), estimated GFR | At Inclusion and two weeks after |
| To determine whether the use of medications with potential dehydrating effects can predict dehydration." | Medication use, osmolarity estimation | Atr inclusion and two weeks after |
| To investigate the prevalence of dehydration | Estimated osmolarity | 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." | 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. | 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 | 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 | 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 | 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 | Enrollment |
| To investigate whether the estimation of body composition is affected by fasting | DXA/BIA scans, 24 hours fasting and a light testmeal | 2 weeks after inclusion |
| Urine sample | Will be conducted in parallel with the mGFRDBS procedure, to measure the albumine kreatinine ratio. | To be carried out just before the commencement of the mGFRDBS procedure. |
| Patient demographics | Marital status (single/cohabiting), education level (highest completed education/schooling), lifestyle (PAL or EQ-5D-5L), functional status (CAS), smoking, alcohol consumption, residential status, municipal assistance/care." | Conducted at enrollment |
| D052801 | Male Urogenital Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |