Methods for Nutrition, Inflammation, Kidney Function, Aging, Body Composition, and Hydration Among Older Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorOve Andersen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 6 trial groups6
Trial groupsSee each trial group below.
Group A: Group 1
Group B: Group 2:
Group C: Group 3:
Group D: Group 4:
Group E: Group 5:
Group F: Group 6:
Trial outcomes
Primary outcomes
1
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 frame
Time of inclusion and/or 14 days after preliminary inclusion.2
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)3
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)4
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)Secondary outcomes
1
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 treatment2
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)3
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)4
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)Other outcomes
1
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 frame
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.2
Urine sample
Will be conducted in parallel with the mGFRDBS procedure, to measure the albumine kreatinine ratio.
Time frame
To be carried out just before the commencement of the mGFRDBS procedure.3
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."
Time frame
Conducted at enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ove Andersen
Lead sponsor
Hvidovre University Hospital
Sponsor institution
Hvidovre University Hospital
Collaborator
Source ClinicalTrials.gov