DialysisNCT03910426
Prognostic Determinants of Survival and Quality of Life in Prevalent End-stage Kidney Disease Patients
An observational study of Dialysis and Quality of Life, run by University Hospital, Ghent.
Trial summary
Patients with end-stage kidney disease are treated with dialysis to increase their life expectancy as well as their quality of life (QoL). Scientific researchers are currently still looking for markers to evaluate dialysis in an objective way. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dialysis, Quality of Life, Nutrition
- What is being tested?
- Blood sampling, Nails collection and Stool collection
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2015to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adult patients treated with dialysis were eligible for inclusion
Who may be able to join
- end-stage kidney disease patients treated with dialysis (peritoneal dialysis or hemodialysis)
Who cannot join
- active inflammation
- malignancy
- cognitive disorder
- not understanding the dutch language
About this study
Official title: Prognostic Determinants (Nutritional Versus Functional Versus Biochemical) of Survival and Quality of Life in Prevalent End-stage Kidney Disease Patients Treated With Dialysis
Patients with end-stage kidney disease are treated with dialysis to increase their life expectancy as well as their quality of life (QoL). Scientific researchers are currently still looking for markers to evaluate dialysis in an objective way. It has been proven before that the currently clinically used parameters (like the dialysis adequacy parameter Kt/V) are not appropriate enough to estimate dialysis dose.
The current project aims at identifying potential (predicting) biomarkers based on functional capacity, nutritional status and/or QoL.
Read the detailed description
This multisite study is an observational study during which prevalent dialysis patients are followed during maximum 3 years, and they undergo different tests.
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
- Dialysis, Quality of Life, Nutrition
- Being tested
- Blood sampling, Nails collection, Stool collection, Physical Functioning, Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood is sampled before a midweek dialysis session once every year with a maximum of 3 samples in total.
Nails collectionOther
At the occasion of the blood sampling, finger nails are cut and collected.
Stool collectionOther
At the occasion of the blood sampling, patients are asked to bring a stool sample.
Physical FunctioningOther
A subgroup of patients are asked to perform some physical tests.
SleepOther
A subgroup of patients are asked to sleep 2-3 nights with a Motionwatch (Actigraphy) to recording their arm movements.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between protein-bound uremic toxin concentrations and physical parameter 6 minute walking test (6MWT)
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. As physical parameters, the 6MWT (m) is performed.
Measured: 10/2015 - 12/2018
Correlation between protein-bound uremic toxin concentrations and physical parameter sit-to-stand test
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. As physical parameters, the sit-to-stand test is performed (sec).
Measured: 10/2015 - 12/2018
Correlation between protein-bound uremic toxin concentrations and muscle strength
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. Muscles strength is measured with handgrip test (N) and quadriceps test (N).
Measured: 10/2015 - 12/2018
Correlation between protein-bound uremic toxin concentrations and risk of fall
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. An adaptation of the Dialysis Fall Risk Index is used as parameter for risk of fall (maximum score 12 - higher risk for higher score).
Measured: 10/2015 - 12/2018
Correlation between protein-bound uremic toxin concentrations and nutritional status
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. Nutritional status is scored using the Mini Nutritional Assessment (MNA) questionnaire (score 24-30: normal nutritional status; 17-23.5: risk for malnutrition; 0-17: malnutrition)
Measured: 10/2015 - 12/2018
Correlation between protein-bound uremic toxin concentrations and quality of life (EQ-5D)
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15 - lower QoL for higher score).
Measured: 10/2015 - 12/2018
Correlation between protein-bound uremic toxin concentrations and quality of life (Promis)
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score - 40-60: normal score).
Measured: 10/2015 - 12/2018
Correlation between protein-bound uremic toxin concentrations and objective sleep parameter (sleep efficiency)
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. The objective parameter 'sleep efficiency' (%) is derived from actigraphy measurement (better sleep for higher %).
Measured: 10/2015 - 12/2018
Correlation between protein-bound uremic toxin concentrations and objective sleep parameter (fragmentation index)
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. The objective parameter 'fragmentation index' (higher score is worse) is derived from actigraphy measurement.
Measured: 10/2015 - 12/2018
Correlation between protein-bound uremic toxin concentrations and patient survival
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. Survival is measured (in months).
Measured: 10/2015 - 12/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start15 Oct 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DialysisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Sponsor
- Investigators
- Wim Van Biesen, PhD, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910426
- Sponsor's protocol ID
- UGent_EQ5D
- Status last verified
- May 2023
- First submitted
- 1 Apr 2019
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32730305
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Determinants (Nutritional Versus Functional Versus Biochemical) of Survival and Quality of Life in Prevalent End-stage Kidney Disease Patients Treated With Dialysis
- ClinicalTrials.gov ID
- NCT03910426
- Acronym / sponsor ID
- UGent_EQ5D
- Conditions
- Dialysis, Quality of Life, Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with end-stage kidney disease are treated with dialysis to increase their life expectancy as well as their quality of life (QoL). Scientific researchers are currently still looking for markers to evaluate dialysis in an objective way. It has been proven before that the currently clinically used parameters (like the dialysis adequacy parameter Kt/V) are not appropriate enough to estimate dialysis dose.
The current project aims at identifying potential (predicting) biomarkers based on functional capacity, nutritional status and/or QoL.
Detailed description
This multisite study is an observational study during which prevalent dialysis patients are followed during maximum 3 years, and they undergo different tests.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients treated with dialysis were eligible for inclusion
Key inclusion criteria (1 listed)
- end-stage kidney disease patients treated with dialysis (peritoneal dialysis or hemodialysis)
Key exclusion criteria (4 listed)
- active inflammation
- malignancy
- cognitive disorder
- not understanding the dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood is sampled before a midweek dialysis session once every year with a maximum of 3 samples in total. | Other | – |
| Nails collectionAt the occasion of the blood sampling, finger nails are cut and collected. | Other | – |
| Stool collectionAt the occasion of the blood sampling, patients are asked to bring a stool sample. | Other | – |
| Physical FunctioningA subgroup of patients are asked to perform some physical tests. | Other | – |
| SleepA subgroup of patients are asked to sleep 2-3 nights with a Motionwatch (Actigraphy) to recording their arm movements. | Other | – |
Primary outcome
Correlation between protein-bound uremic toxin concentrations and physical parameter 6 minute walking test (6MWT)
Time frame: 10/2015 - 12/2018
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. As physical parameters, the 6MWT (m) is performed.
Correlation between protein-bound uremic toxin concentrations and physical parameter sit-to-stand test
Time frame: 10/2015 - 12/2018
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. As physical parameters, the sit-to-stand test is performed (sec).
Correlation between protein-bound uremic toxin concentrations and muscle strength
Time frame: 10/2015 - 12/2018
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. Muscles strength is measured with handgrip test (N) and quadriceps test (N).
Correlation between protein-bound uremic toxin concentrations and risk of fall
Time frame: 10/2015 - 12/2018
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. An adaptation of the Dialysis Fall Risk Index is used as parameter for risk of fall (maximum score 12 - higher risk for higher score).
Correlation between protein-bound uremic toxin concentrations and nutritional status
Time frame: 10/2015 - 12/2018
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. Nutritional status is scored using the Mini Nutritional Assessment (MNA) questionnaire (score 24-30: normal nutritional status; 17-23.5: risk for malnutrition; 0-17: malnutrition)
Correlation between protein-bound uremic toxin concentrations and quality of life (EQ-5D)
Time frame: 10/2015 - 12/2018
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15 - lower QoL for higher score).
Correlation between protein-bound uremic toxin concentrations and quality of life (Promis)
Time frame: 10/2015 - 12/2018
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score - 40-60: normal score).
Correlation between protein-bound uremic toxin concentrations and objective sleep parameter (sleep efficiency)
Time frame: 10/2015 - 12/2018
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. The objective parameter 'sleep efficiency' (%) is derived from actigraphy measurement (better sleep for higher %).
Correlation between protein-bound uremic toxin concentrations and objective sleep parameter (fragmentation index)
Time frame: 10/2015 - 12/2018
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. The objective parameter 'fragmentation index' (higher score is worse) is derived from actigraphy measurement.
Correlation between protein-bound uremic toxin concentrations and patient survival
Time frame: 10/2015 - 12/2018
Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. Survival is measured (in months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Derived from this study: PubMed 32730305Vanden 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wim Van Biesen, PhD, MD principal investigator
University Hospital, Ghent
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis and Quality of Life, run by University Hospital, Ghent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between protein-bound uremic toxin concentrations and physical parameter 6 minute walking test (6MWT) (time frame: 10/2015 - 12/2018). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03910426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.