Prognostic Determinants of Survival and Quality of Life in Prevalent End-stage Kidney Disease Patients
NCT ID: NCT03910426
Last Updated: 2023-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
216 participants
OBSERVATIONAL
2015-10-15
2018-12-31
Brief Summary
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The current project aims at identifying potential (predicting) biomarkers based on functional capacity, nutritional status and/or QoL.
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Detailed Description
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Once a year (max 3 times), blood is sampled, stool is collected, and finger nails are taken all before a midweek session. Demographic data are registered and Davies-Stokes scores are calculated. Blood is analysed for different solutes: e.g. total and free fractions of protein-bound toxins, sedimentation, erythrocytes, hematocrit, leukocytes, thrombocytes, Ferritin, VitB12, Fasting glucose, c-reactive protein, urea, creatinine, albumin, total protein, cholesterol, triglycerides, bilirubin,...
At the same occasion, patients are questioned about different items (QoL, nutrition) by a (study) nurse or coordinator, using different questionnaires: Euroqol 5 dimension scale (EQ-5D), Patient-Reported Outcomes Measurement Information System (Promis-29), and Mini Nutritional Assessment (MNA).
A subgroup of patients were asked to perform some functional tests: Tinetti-Test, Sit to Stand (5 times), Frailty and Injuries: Cooperative Studies on Intervention Techniques (Ficsit) test, 2 or 6 minutes walking test, handgrip strength and quadriceps power measurement, back scratch test, compensatory stepping correction-backward test and skin fold measurement. All tests are non-invasive and are validated for routine measurements in the elderly.
In order to quantify sleep, patients were asked to wear a Motionwatch (Actigraphy) to register their arm movements during 2 or 3 nights as well as to fill out 2 questionnaires related to sleep: Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI). To compare sleep in dialysis patients with healthy persons, age and gender matched healthy volunteers were also included in the study and were asked to sleep 2 or 3 nights with the Motionwatch and to complete the ISI and PSQI.
Patients who were transplanted got an extra blood sampling just before transplantation as well as 4 months after transplantation.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Blood sampling
Blood is sampled before a midweek dialysis session once every year with a maximum of 3 samples in total.
Nails collection
At the occasion of the blood sampling, finger nails are cut and collected.
Stool collection
At the occasion of the blood sampling, patients are asked to bring a stool sample.
Physical Functioning
A subgroup of patients are asked to perform some physical tests.
Sleep
A subgroup of patients are asked to sleep 2-3 nights with a Motionwatch (Actigraphy) to recording their arm movements.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* malignancy
* cognitive disorder
* not understanding the dutch language
18 Years
ALL
Yes
Sponsors
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University Hospital, Antwerp
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Wim Van Biesen, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
References
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Vanden Wyngaert K, Celie B, Calders P, Eloot S, Holvoet E, Van Biesen W, Van Craenenbroeck AH. Markers of protein-energy wasting and physical performance in haemodialysis patients: A cross-sectional study. PLoS One. 2020 Jul 30;15(7):e0236816. doi: 10.1371/journal.pone.0236816. eCollection 2020.
Other Identifiers
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UGent_EQ5D
Identifier Type: -
Identifier Source: org_study_id
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