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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Dialysis; Nutrition
• Intervention / Treatment: Other: Blood sampling; Other: Nails collection; Other: Stool collection; Other: Physical Functioning; Other: Sleep

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 Type: Observational
• Enrollment (Actual): 216

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All adult patients treated with dialysis were eligible for inclusion

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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).	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)	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).	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).	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 %).	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.	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).	10/2015 - 12/2018

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between objectively measured sleep quality (sleep efficiency) in dialysis patients versus healthy controls	The objective parameter 'sleep efficiency' (%) is derived from actigraphy measurement and is compared between dialysis patients and age and gender matched healthy volunteers.	2016-2018
Difference between objectively measured sleep quality (fragmentation index) in dialysis patients versus healthy controls	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.	2016-2018
Difference between subjectively measured sleep quality (ISI) in dialysis patients versus healthy controls	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).	2016-2018
Difference between subjectively measured sleep quality (PSQI) in dialysis patients versus healthy controls	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).	2016-2018
Difference between the MNA scores for the short form (screening score) and the MNA score of the full form (indication score)	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.	10/2015-12/2018
Correlation between subjective QoL score (EQ-5D) and physical parameter 6 minute walking test (6MWT)	Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15). As physical parameters, the 6MWT (m) is performed.	10/2015-12/2018
Correlation between subjective QoL score (Promis) and physical parameter 6 minute walking test (6MWT)	Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score). As physical parameters, the 6MWT (m) is performed.	10/2015-12/2018
Correlation between subjective QoL score (EQ-5D) and physical parameter sit-to-stand test	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.	10/2015-12/2018
Correlation between subjective QoL score (Promis) and physical parameter sit-to-stand test	Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score). As physical parameters, the sit-to-stand test (sec) is performed.	10/2015-12/2018
Correlation between subjective QoL score (EQ-5D) and muscle strength	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).	10/2015-12/2018
Correlation between subjective QoL score (Promis) and muscle strength	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).	10/2015-12/2018
Correlation between subjective QoL score (EQ-5D) and risk of fall	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).	10/2015-12/2018
Correlation between subjective QoL score (Promis) and risk of fall	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).	10/2015-12/2018
Correlation between subjective QoL score (EQ-5D) and nutritional status	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)	10/2015-12/2018
Correlation between subjective QoL score (Promis) and nutritional status	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)	10/2015-12/2018
Correlation between subjective QoL score (EQ-5D) and the objective sleep parameter (sleep efficiency)	Quality of life (QoL) is scored using the EQ-5D questionnaire (score 5-15). The objective parameter 'sleep efficiency' (%) is derived from actigraphy measurement.	10/2015-12/2018
Correlation between subjective QoL score (Promis) and the objective sleep parameter (sleep efficiency)	Quality of life (QoL) is scored using the Promis questionnaire (standard deviation score). The objective parameter 'sleep efficiency' (%) is derived from actigraphy measurement.	10/2015-12/2018
Correlation between subjective QoL score (EQ-5D) and the objective sleep parameter (fragmentation index)	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.	10/2015-12/2018
Correlation between subjective QoL score (Promis) and the objective sleep parameter (fragmentation index)	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.	10/2015-12/2018

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Hospital, Antwerp
• Investigators: Principal Investigator: Wim Van Biesen, PhD, MD, University Hospital, Ghent

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2015
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: UGent_EQ5D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No