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NCT Number: NCT03910426

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

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.

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Key information

Conditions

Dialysis Nutrition Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

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

Nails collection

Other

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

Stool collection

Other

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

Physical Functioning

Other

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

Sleep

Other

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

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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).

  5. 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)

  6. 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).

  7. 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).

  8. 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 %).

  9. 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.

  10. 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).

Other outcomes

  1. Difference between objectively measured sleep quality (sleep efficiency) in dialysis patients versus healthy controls

    Time frame: 2016-2018

    The objective parameter 'sleep efficiency' (%) is derived from actigraphy measurement and is compared between dialysis patients and age and gender matched healthy volunteers.

  2. Difference between objectively measured sleep quality (fragmentation index) in dialysis patients versus healthy controls

    Time frame: 2016-2018

    The 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.

  3. Difference between subjectively measured sleep quality (ISI) in dialysis patients versus healthy controls

    Time frame: 2016-2018

    Subjective 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).

  4. Difference between subjectively measured sleep quality (PSQI) in dialysis patients versus healthy controls

    Time frame: 2016-2018

    Subjective 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).

  5. Difference between the MNA scores for the short form (screening score) and the MNA score of the full form (indication score)

    Time frame: 10/2015-12/2018

    From 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.

  6. Correlation between subjective QoL score (EQ-5D) and physical parameter 6 minute walking test (6MWT)

    Time frame: 10/2015-12/2018

    Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15). As physical parameters, the 6MWT (m) is performed.

  7. Correlation between subjective QoL score (Promis) and physical parameter 6 minute walking test (6MWT)

    Time frame: 10/2015-12/2018

    Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score).

    As physical parameters, the 6MWT (m) is performed.

  8. Correlation between subjective QoL score (EQ-5D) and physical parameter sit-to-stand test

    Time frame: 10/2015-12/2018

    Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15). As physical parameters, the sit-to-stand test (sec) is performed.

  9. Correlation between subjective QoL score (Promis) and physical parameter sit-to-stand test

    Time frame: 10/2015-12/2018

    Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score).

    As physical parameters, the sit-to-stand test (sec) is performed.

  10. Correlation between subjective QoL score (EQ-5D) and muscle strength

    Time frame: 10/2015-12/2018

    Quality 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).

  11. Correlation between subjective QoL score (Promis) and muscle strength

    Time frame: 10/2015-12/2018

    Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score).

    Muscles strength is measured with handgrip test (N) and quadriceps test (N).

  12. Correlation between subjective QoL score (EQ-5D) and risk of fall

    Time frame: 10/2015-12/2018

    Quality 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).

  13. Correlation between subjective QoL score (Promis) and risk of fall

    Time frame: 10/2015-12/2018

    Quality 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).

  14. Correlation between subjective QoL score (EQ-5D) and nutritional status

    Time frame: 10/2015-12/2018

    Quality 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)

  15. Correlation between subjective QoL score (Promis) and nutritional status

    Time frame: 10/2015-12/2018

    Quality 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)

  16. Correlation between subjective QoL score (EQ-5D) and the objective sleep parameter (sleep efficiency)

    Time frame: 10/2015-12/2018

    Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15). The objective parameter 'sleep efficiency' (%) is derived from actigraphy measurement.

  17. Correlation between subjective QoL score (Promis) and the objective sleep parameter (sleep efficiency)

    Time frame: 10/2015-12/2018

    Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score).

    The objective parameter 'sleep efficiency' (%) is derived from actigraphy measurement.

  18. Correlation between subjective QoL score (EQ-5D) and the objective sleep parameter (fragmentation index)

    Time frame: 10/2015-12/2018

    Quality 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.

  19. Correlation between subjective QoL score (Promis) and the objective sleep parameter (fragmentation index)

    Time frame: 10/2015-12/2018

    Quality 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Hospital, Antwerp

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2019
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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