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Prognostic Determinants of Survival and Quality of Life in Prevalent End-stage Kidney Disease Patients

Prognostic Determinants (Nutritional Versus Functional Versus Biochemical) of Survival and Quality of Life in Prevalent End-stage Kidney Disease Patients Treated With Dialysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03910426
Enrollment
216
Registered
2019-04-10
Start date
2015-10-15
Completion date
2018-12-31
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis, Nutrition, Quality of Life

Brief 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. 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.

Interventions

OTHERPhysical Functioning

A subgroup of patients are asked to perform some physical tests.

OTHERSleep

A subgroup of patients are asked to sleep 2-3 nights with a Motionwatch (Actigraphy) to recording their arm movements.

OTHERBlood sampling

Blood is sampled before a midweek dialysis session once every year with a maximum of 3 samples in total.

OTHERNails collection

At the occasion of the blood sampling, finger nails are cut and collected.

OTHERStool collection

At the occasion of the blood sampling, patients are asked to bring a stool sample.

Sponsors

University Hospital, Antwerp
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\- end-stage kidney disease patients treated with dialysis (peritoneal dialysis or hemodialysis)

Exclusion criteria

* active inflammation * malignancy * cognitive disorder * not understanding the dutch language

Design outcomes

Primary

MeasureTime frameDescription
Correlation between protein-bound uremic toxin concentrations and physical parameter 6 minute walking test (6MWT)10/2015 - 12/2018Blood 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 test10/2015 - 12/2018Blood 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 strength10/2015 - 12/2018Blood 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 fall10/2015 - 12/2018Blood 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 status10/2015 - 12/2018Blood 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)10/2015 - 12/2018Blood 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)10/2015 - 12/2018Blood 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)10/2015 - 12/2018Blood 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)10/2015 - 12/2018Blood 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 survival10/2015 - 12/2018Blood samples are analysed for protein-bound toxins (mg/dL) in one High Performance Liquid Chromatography run. Survival is measured (in months).

Other

MeasureTime frameDescription
Correlation between subjective QoL score (Promis) and muscle strength10/2015-12/2018Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score). Muscles strength is measured with handgrip test (N) and quadriceps test (N).
Correlation between subjective QoL score (EQ-5D) and risk of fall10/2015-12/2018Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15 - lower QoL for higher score). 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 subjective QoL score (Promis) and risk of fall10/2015-12/2018Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score - 40-60 normal score). 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 subjective QoL score (EQ-5D) and nutritional status10/2015-12/2018Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15). 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)
Difference between objectively measured sleep quality (sleep efficiency) in dialysis patients versus healthy controls2016-2018The objective parameter 'sleep efficiency' (%) is derived from actigraphy measurement and is compared between dialysis patients and age and gender matched healthy volunteers.
Correlation between subjective QoL score (EQ-5D) and the objective sleep parameter (sleep efficiency)10/2015-12/2018Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15). The objective parameter 'sleep efficiency' (%) is derived from actigraphy measurement.
Correlation between subjective QoL score (Promis) and the objective sleep parameter (sleep efficiency)10/2015-12/2018Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score). The objective parameter 'sleep efficiency' (%) is derived from actigraphy measurement.
Correlation between subjective QoL score (EQ-5D) and the objective sleep parameter (fragmentation index)10/2015-12/2018Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15). The objective parameter 'fragmentation index' (higher score is worse) is derived from actigraphy measurement.
Correlation between subjective QoL score (Promis) and the objective sleep parameter (fragmentation index)10/2015-12/2018Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score). The objective parameter 'fragmentation index' (higher score is worse) is derived from actigraphy measurement.
Correlation between subjective QoL score (Promis) and nutritional status10/2015-12/2018Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score). 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)
Difference between objectively measured sleep quality (fragmentation index) in dialysis patients versus healthy controls2016-2018The objective parameter 'fragmentation index' (higher score is worse) is derived from actigraphy measurement and is compared between dialysis patients and age and gender matched healthy volunteers.
Difference between subjectively measured sleep quality (ISI) in dialysis patients versus healthy controls2016-2018Subjective sleep parameter, as calculated from the Insomnia Severity Index (ISI) questionnaire, is compared between dialysis patients and age and gender matched healthy volunteers. The ISI score is 0-28 (the lower the better).
Difference between subjectively measured sleep quality (PSQI) in dialysis patients versus healthy controls2016-2018Subjective sleep parameter, as calculated from the Pittsburgh Sleep Quality Index (PSQI) questionnaire, is compared between dialysis patients and age and gender matched healthy volunteers. The ISI score is 0-27 (the lower the better).
Difference between the MNA scores for the short form (screening score) and the MNA score of the full form (indication score)10/2015-12/2018From the MNA questionnaire, the screening and indication scores are calculated and patients are for each score allocated to a group according to their score: i.e. normal nutritional status, risk for malnutrition, and malnutrition. Screening score: 12-14: normal nutritional status; 8-11: risk for malnutrition; 0-7: malnutrition. Indication score: 24-30: normal nutritional status; 17-23.5: risk for malnutrition; 0-17: malnutrition.
Correlation between subjective QoL score (EQ-5D) and physical parameter 6 minute walking test (6MWT)10/2015-12/2018Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15). As physical parameters, the 6MWT (m) is performed.
Correlation between subjective QoL score (Promis) and physical parameter 6 minute walking test (6MWT)10/2015-12/2018Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score). As physical parameters, the 6MWT (m) is performed.
Correlation between subjective QoL score (EQ-5D) and physical parameter sit-to-stand test10/2015-12/2018Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15). As physical parameters, the sit-to-stand test (sec) is performed.
Correlation between subjective QoL score (Promis) and physical parameter sit-to-stand test10/2015-12/2018Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score). As physical parameters, the sit-to-stand test (sec) is performed.
Correlation between subjective QoL score (EQ-5D) and muscle strength10/2015-12/2018Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15). Muscle strength is measured with handgrip test (N) and quadriceps test (N).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026