Dehydr8 and Deactiv8

NCT03179072 | Completed DMC

• 1 other identifier: ZS001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (17)

• 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

  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

  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

  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

  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

  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)

  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)

  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)

  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)

  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)

  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).

  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

  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

  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)

  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)

  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

  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

  Continuous during 8 days (sleep diary each morning)

Secondary Outcomes (4)

• Assessment of acceptability

  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)

  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)

  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)

  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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Portsmouth: lead
• Portsmouth Hospitals NHS Trust: collaborator
• Swansea University: collaborator
• Bangor University: collaborator

Study Sites (1)

Queen Alexandra Hospital

Portsmouth, Hampshire, PO6, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Physical Activity, Exercise and Health

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: June 7, 2017
• Study Start: July 19, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)