End Stage Renal DiseaseNCT03179072
Dehydr8 and Deactiv8
An observational study of End Stage Renal Disease, run by University of Portsmouth at 1 site in United Kingdom.
Trial summary
Managing fluid status is a complex but fundamental part of the clinical care of people receiving haemodialysis (HD). Day-to-day fluid management is usually based on the concept of 'target weight' - the weight used to determine how much fluid should be removed during each dialysis session. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jul 2017to 1 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults with end-stage renal disease receiving in-hospital haemodialysis at the Wessex Kidney Centre will be invited to participate. This centre cares for ~700 HD patients, of which ~120 receive in-hospital HD three times a week. As more males have ESRD, it is likely that we will have a higher proportion of males. Participant's clinical records will remain at the hospital as usual.
Who may be able to join
- The participant must meet ALL of the following criteria to be considered eligible for the study:
- Male or female > 18 years of age with ESRD and on maintenance HD for > 3 months
- Haemoglobin > 10 mg/dL
- Participant is willing and able to give informed consent for participation in the study
- Participant can understand and cooperate with the study protocol
Who cannot join
- The participant may not enter the study if ANY of the following criteria apply:
- Haemoglobin ≤ 10 mg/dL
- Unable to understand or cooperate with the study protocol
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6
About this study
Official title: The Impact of a Typical 8 Day Course of 'Target Weight' Driven Haemodialysis on the Hydration Status, Physical and Cognitive Function, Physical Activity and Quality of Life of Adults With End-stage Renal Disease.
Managing fluid status is a complex but fundamental part of the clinical care of people receiving haemodialysis (HD). Day-to-day fluid management is usually based on the concept of 'target weight' - the weight used to determine how much fluid should be removed during each dialysis session. However, the focus of this approach is usually on avoiding fluid overload (hypervolaemia), since this is associated with a higher incidence of cardiovascular and pulmonary events, in addition to increased morbidity and morbidity. As a consequence, a significant proportion of people on maintenance HD spend a great deal of time in a dehydrated state. Although dehydration is known to be associated with a number of unwanted consequences (e.g. headaches, severe fatigue, impaired cognitive and physiological function), there has been little research focusing on the impact dehydration has on the physical and psychosocial well-being of this patient group. Considering the short life expectancy of individuals with end-stage renal disease (ESRD) reliant on maintenance HD, particularly those who are unable to receive a renal transplant, we should be focused on improving their function and quality of life (QoL).
Key issues that need addressing prior to developing interventions in this cohort are 1) investigating the best and alternative measures to assess hydration status and 2) documenting the biopsychosocial impact of typical target weight driven HD in a well-designed study.
Read the detailed description
End-stage renal disease (ESRD) represents the final common pathway for all progressive renal disease. As of December 2014, 58,968 people in the UK were receiving renal replacement therapy (RRT), of which almost half were receiving maintenance haemodialysis (HD; UK Renal Registry Report (2014)). The Wessex Kidney Centre cares for ~1,600 patients receiving RRT, of which >700 receive HD. The median age of our cohort is 66.7 years, similar to that of all incident UK-based patients in 2014 (64.5 years). The RRT recipient population is however growing and, increasingly, patients are more elderly with comorbidities. These individuals are unlikely to receive transplantation and will therefore depend on dialysis indefinitely. Optimising their quality of life (QoL) should be a priority.
Currently, a standard HD prescription includes a specific volume of ultrafiltration, set to achieve a clinically derived estimate of 'target weight'. Acutely, hypervolaemia (fluid overload) can be life threatening, whilst chronically it is associated with hypertension and an increased cardiovascular risk. Accordingly, target weight is typically prescribed to allow for interdialytic weight gains. The sequential reduction of target weight to achieve the lowest possible target weight (dry weight probing), thought to improve blood pressure (BP) control, left ventricular mass index and long-term outcomes, is favoured by many nephrologists. However, this results in dehydration and is associated with increased intradialytic symptoms, including intradialytic hypotension, which itself brings an increased risk of cardiac death. Local data from the Wessex Kidney Centre suggests that patients experiencing a greater drop in systolic BP pre- to post-dialysis are more likely to experience symptomatic hypotension during dialysis. Intradialytic BP variability is also detrimental to long-term outcomes. Achieving ideal hydration is therefore important for not only reducing symptomatology, but also improving BP control and cardiovascular health in these patients. Poor cardiovascular health contributes to the reduced physical function characterising this group, which along with physical (in)activity is associated with a poorer prognosis in this patient group. Furthermore, increased rates of depression and cardiovascular disease have been associated with poor physical function in this group.
There is, however, little research documenting how dehydration impacts individuals undergoing dialysis. Specifically, few studies have assessed the link between (de)hydration and frailty, although better physical function has been associated with a higher pre-dialysis BP, which may simply reflect better hydration. Experience from the Wessex Kidney Centre suggests that dehydrated dialysis patients suffer from increasing intradialytic symptomatology and a prolonged dialysis recovery time, during which they complain of prolonged fatigue. However, no studies have documented whether improving the hydration of dialysis patients improves not only their intra- and interdialytic symptomatology, but also their physiological/cognitive function, fatigue, physical (in)activity and, ultimately, QoL. Establishing the relationships between dehydration and these outcomes is essential, since hydration status can be easily and rapidly adjusted. One reason there is limited research in this area is that hydration status of individuals undergoing dialysis is difficult to objectively assess, which itself warrants further investigation.
- Conditions
- End Stage Renal Disease
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
HHYDRATION STATUS - Change in saliva osmolality following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in saliva osmolality (BIA), sit-to-stand changes in heart rate, thirst perception scale
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Hydration status - Change in plasma osmolality following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in plasma osmolality
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Hydration status - Change in bioelectrical impedance analysis following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in bioelectrical impedance analysis
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Hydration status - change in saliva flow rate following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in saliva flow rate
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Thirst perception - Change in thirst perception following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in simple rating on visual analogue scale
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Physical function - change in physical function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in muscular endurance (heel rises)
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Physical function - change in physical function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in muscular endurance (30-seconds sit-to-stand)
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Physical function - change in physical function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in muscular endurance (toe lifts)
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Physical function - change in physical function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in fine motor skills (Moberg's picking-up test)
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Physical function - Change in physical function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in muscle strength (handgrip strength)
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Physical function - change in physical function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in endurance and walking capacity in patients capable of doing so (6 minute walk test).
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Cognitive function - change in cognitive function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in cognitive function - KDQoL Questionnaire
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis (day 8)
Cognitive function - change in cognitive function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in cognitive function - EQ-5D-5L Questionnaire
Measured: Baseline (day 1: pre-dialysis 1), pre-dialysis (day 3), pre-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Cognitive function - change in cognitive function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change from baseline in cognitive function - EQ-5D-5L Questionnaire (part 2 repeated only)
Measured: Post-dialysis (day 1), similar time of day (day 2), post-dialysis (day 3), similar time of day (day 4), post-dialysis (day 5), similar time of day (day 6), similar time of day (day 7), post-dialysis (day 8)
Physical Activity following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Accelerometry (hip mounted)
Measured: Continuous for 8 day period
Physical Activity - change in physical activity across typical 8 days of treatment (longer-term)
Change from baseline in physical activity - Rapid Assessment of Physical Activity (RAPA) Questionnaire
Measured: Baseline (day 1: pre-dialysis 1), pre-dialysis (day 8)
Sleep quality following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Accelerometry / sleep diary
Measured: Continuous during 8 days (sleep diary each morning)
Secondary outcomes (4)
Assessment of acceptability
Semi-structured interviews will be used to examine the acceptability of alternative markers of hydration status. Specifically, interviews will explore research methods, and physical and cognitive function, PA, and QoL. Approximately 15-20 semi-structured interviews will be necessary to reach a point of data saturation where no new information is provided.
Measured: Following involvement with the study (within 1 week)
Haemodynamic function - change in haemodynamic function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change in blood pressure
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Haemodynamic function - change in haemodynamic function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Change in ScvO2 - measured in those who dialyse through a central venous catheter
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Haemodynamic function - change in haemodynamic function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Changes in resting heart rate
Measured: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start19 Jul 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust, Swansea University, Bangor University
- Responsible party
- Principal investigator, Dr Zoe Saynor, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179072
- Sponsor's protocol ID
- ZS001
- Status last verified
- Jul 2020
- First submitted
- 26 May 2017
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD, until all avenues of further funding have been exhausted.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Typical 8 Day Course of 'Target Weight' Driven Haemodialysis on the Hydration Status, Physical and Cognitive Function, Physical Activity and Quality of Life of Adults With End-stage Renal Disease.
- ClinicalTrials.gov ID
- NCT03179072
- Acronym / sponsor ID
- ZS001
- Conditions
- End Stage Renal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust, Swansea University, Bangor University
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Managing fluid status is a complex but fundamental part of the clinical care of people receiving haemodialysis (HD). Day-to-day fluid management is usually based on the concept of 'target weight' - the weight used to determine how much fluid should be removed during each dialysis session. However, the focus of this approach is usually on avoiding fluid overload (hypervolaemia), since this is associated with a higher incidence of cardiovascular and pulmonary events, in addition to increased morbidity and morbidity. As a consequence, a significant proportion of people on maintenance HD spend a great deal of time in a dehydrated state. Although dehydration is known to be associated with a number of unwanted consequences (e.g. headaches, severe fatigue, impaired cognitive and physiological function), there has been little research focusing on the impact dehydration has on the physical and psychosocial well-being of this patient group. Considering the short life expectancy of individuals with end-stage renal disease (ESRD) reliant on maintenance HD, particularly those who are unable to receive a renal transplant, we should be focused on improving their function and quality of life (QoL).
Key issues that need addressing prior to developing interventions in this cohort are 1) investigating the best and alternative measures to assess hydration status and 2) documenting the biopsychosocial impact of typical target weight driven HD in a well-designed study.
Detailed description
End-stage renal disease (ESRD) represents the final common pathway for all progressive renal disease. As of December 2014, 58,968 people in the UK were receiving renal replacement therapy (RRT), of which almost half were receiving maintenance haemodialysis (HD; UK Renal Registry Report (2014)). The Wessex Kidney Centre cares for ~1,600 patients receiving RRT, of which >700 receive HD. The median age of our cohort is 66.7 years, similar to that of all incident UK-based patients in 2014 (64.5 years). The RRT recipient population is however growing and, increasingly, patients are more elderly with comorbidities. These individuals are unlikely to receive transplantation and will therefore depend on dialysis indefinitely. Optimising their quality of life (QoL) should be a priority.
Currently, a standard HD prescription includes a specific volume of ultrafiltration, set to achieve a clinically derived estimate of 'target weight'. Acutely, hypervolaemia (fluid overload) can be life threatening, whilst chronically it is associated with hypertension and an increased cardiovascular risk. Accordingly, target weight is typically prescribed to allow for interdialytic weight gains. The sequential reduction of target weight to achieve the lowest possible target weight (dry weight probing), thought to improve blood pressure (BP) control, left ventricular mass index and long-term outcomes, is favoured by many nephrologists. However, this results in dehydration and is associated with increased intradialytic symptoms, including intradialytic hypotension, which itself brings an increased risk of cardiac death. Local data from the Wessex Kidney Centre suggests that patients experiencing a greater drop in systolic BP pre- to post-dialysis are more likely to experience symptomatic hypotension during dialysis. Intradialytic BP variability is also detrimental to long-term outcomes. Achieving ideal hydration is therefore important for not only reducing symptomatology, but also improving BP control and cardiovascular health in these patients. Poor cardiovascular health contributes to the reduced physical function characterising this group, which along with physical (in)activity is associated with a poorer prognosis in this patient group. Furthermore, increased rates of depression and cardiovascular disease have been associated with poor physical function in this group.
There is, however, little research documenting how dehydration impacts individuals undergoing dialysis. Specifically, few studies have assessed the link between (de)hydration and frailty, although better physical function has been associated with a higher pre-dialysis BP, which may simply reflect better hydration. Experience from the Wessex Kidney Centre suggests that dehydrated dialysis patients suffer from increasing intradialytic symptomatology and a prolonged dialysis recovery time, during which they complain of prolonged fatigue. However, no studies have documented whether improving the hydration of dialysis patients improves not only their intra- and interdialytic symptomatology, but also their physiological/cognitive function, fatigue, physical (in)activity and, ultimately, QoL. Establishing the relationships between dehydration and these outcomes is essential, since hydration status can be easily and rapidly adjusted. One reason there is limited research in this area is that hydration status of individuals undergoing dialysis is difficult to objectively assess, which itself warrants further investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults with end-stage renal disease receiving in-hospital haemodialysis at the Wessex Kidney Centre will be invited to participate. This centre cares for ~700 HD patients, of which ~120 receive in-hospital HD three times a week. As more males have ESRD, it is likely that we will have a higher proportion of males. Participant's clinical records will remain at the hospital as usual.
Key inclusion criteria (5 listed)
- The participant must meet ALL of the following criteria to be considered eligible for the study:
- Male or female > 18 years of age with ESRD and on maintenance HD for > 3 months
- Haemoglobin > 10 mg/dL
- Participant is willing and able to give informed consent for participation in the study
- Participant can understand and cooperate with the study protocol
Key exclusion criteria (3 listed)
- Haemoglobin ≤ 10 mg/dL
- Unable to understand or cooperate with the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HHYDRATION STATUS - Change in saliva osmolality following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Change from baseline in saliva osmolality (BIA), sit-to-stand changes in heart rate, thirst perception scale
Hydration status - Change in plasma osmolality following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Change from baseline in plasma osmolality
Hydration status - Change in bioelectrical impedance analysis following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Change from baseline in bioelectrical impedance analysis
Hydration status - change in saliva flow rate following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Change from baseline in saliva flow rate
Thirst perception - Change in thirst perception following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Change from baseline in simple rating on visual analogue scale
Physical function - change in physical function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Change from baseline in muscular endurance (heel rises)
Physical function - change in physical function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Change from baseline in muscular endurance (30-seconds sit-to-stand)
Physical function - change in physical function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Change from baseline in muscular endurance (toe lifts)
Physical function - change in physical function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Change from baseline in fine motor skills (Moberg's picking-up test)
Physical function - Change in physical function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Change from baseline in muscle strength (handgrip strength)
Physical function - change in physical function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Change from baseline in endurance and walking capacity in patients capable of doing so (6 minute walk test).
Cognitive function - change in cognitive function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis (day 8)
Change from baseline in cognitive function - KDQoL Questionnaire
Cognitive function - change in cognitive function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), pre-dialysis (day 3), pre-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Change from baseline in cognitive function - EQ-5D-5L Questionnaire
Cognitive function - change in cognitive function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Post-dialysis (day 1), similar time of day (day 2), post-dialysis (day 3), similar time of day (day 4), post-dialysis (day 5), similar time of day (day 6), similar time of day (day 7), post-dialysis (day 8)
Change from baseline in cognitive function - EQ-5D-5L Questionnaire (part 2 repeated only)
Physical Activity following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Continuous for 8 day period
Accelerometry (hip mounted)
Physical Activity - change in physical activity across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), pre-dialysis (day 8)
Change from baseline in physical activity - Rapid Assessment of Physical Activity (RAPA) Questionnaire
Sleep quality following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Continuous during 8 days (sleep diary each morning)
Accelerometry / sleep diary
4 secondary outcomes
Assessment of acceptability
Time frame: Following involvement with the study (within 1 week)
Haemodynamic function - change in haemodynamic function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Haemodynamic function - change in haemodynamic function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Haemodynamic function - change in haemodynamic function following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term)
Time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No. There is no plan to share IPD, until all avenues of further funding have been exhausted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease, run by University of Portsmouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HHYDRATION STATUS - Change in saliva osmolality following a single session of haemodialysis (short-term) and across typical 8 days of treatment (longer-term) (time frame: Baseline (day 1: pre-dialysis 1), post-dialysis 1 (day 1), pre-dialysis (day 3), post-dialysis (day 3), pre-dialysis (day 5), post-dialysis (day 5), pre-dialysis (day 8), post-dialysis (day 8)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.