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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03910426
• Other study ID #: UGent_EQ5D
• Status: Completed
• Start date: October 15, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dialysis
• Kidney Diseases
• Kidney Failure, Chronic
• Nutrition
• Quality of Life

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Hospital, Antwerp

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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