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

NCT03910426 | Completed

• 1 other identifier: UGent_EQ5D
• Study Type: observational
• Target: 216
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dialysis; Quality of Life; Nutrition

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (19)

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

  2016-2018

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

  2016-2018

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

  2016-2018

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients treated with dialysis were eligible for inclusion

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Hospital, Antwerp: collaborator

Related Publications (1)

• 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.

  PMID: 32730305 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection of blood, stool and nails

MeSH Terms

Interventions

Blood Specimen Collection; Sleep

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Wim Van Biesen, PhD, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 10, 2019
• Study Start: October 15, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share