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Evaluation of the Effect of Cooled Haemodialysis on Cognitive Function in Patients Suffering With End-stage KD (E-CHECKED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03645733
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Heart of England NHS Trust

Brief Summary:
The Investigators aim to perform a feasibility study that will inform the development of a definitive, fully powered, randomised, controlled clinical trial in the future. The main hypothesis that would be tested in this future trial is that patients treated with regular conventional haemodialysis will have a lesser decline in cognitive function and a better quality of life over one year by using cooler dialysis fluid at 35°C, versus a standard dialysis fluid temperature of 36.5°C. This also should reflect in improvements in their abilities for activities of daily living and therefore, reduce carers' burden. If successful the treatment could be universally applied at no extra cost.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Procedure: Lower Temperature Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The control group will be at the standard dialysate temperature of 36.5 °C (which is the standard of care in the sites), 3 times a week for 12 months. In the intervention group, patients will receive haemodialysis with a dialysate temperature of 35 degree centigrade. The intervention group will start off using a dialysate temperature that is 36 °C. Thereafter the dialysate temperature will be reduced every two week by 0.5 °C until 35 °C or the lowest tolerated temperature reached. Patients who would fail to tolerate the temperature of 35 °C, the lowest tolerated temperature will be carried over to the end of the study. The intervention group is split into 3 brackets, stratified by age group (patients under 55 years of age, 55-75 and above 75). A third group will also be recruited, but not randomised, consisting of the primary carers (family, friends, etc) of the patients in the other two group to measure the burden they feel in caring for a patient with renal problems.
Masking: Single (Outcomes Assessor)
Masking Description: One nurse, that gives the patients their cognitive questionnaire battery, is masked from knowing which dialysis fluid temperature the patient is receiving.
Primary Purpose: Prevention
Official Title: Evaluation of the Effect of Cooled Haemodialysis on Cognitive Function in Patients Suffering With End-stage Kidney Disease: Feasibility Study
Actual Study Start Date : December 20, 2017
Actual Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
No Intervention: Control Group
The control group will be at the standard dialysate temperature of 36.5 °C (which is the standard of care in the sites), 3 times a week for 12 months
Experimental: Lower Temperature Group
These patients will receive haemodialysis with a dialysate temperature of 35 degree centigrade. The intervention group will start off using a dialysate temperature that is 36 °C. Thereafter the dialysate temperature will be reduced every two week by 0.5 °C until 35 °C or the lowest tolerated temperature reached. Patients who would fail to tolerate the temperature of 35 °C, the lowest tolerated temperature will be carried over to the end of the study.
Procedure: Lower Temperature Group
Dialysate temperature of 35 degree centigrade. The intervention group will start off using a dialysate temperature that is 36 °C. Thereafter the dialysate temperature will be reduced every two week by 0.5 °C until 35 °C or the lowest tolerated temperature reached.

No Intervention: Caregivers
Patients, who consent for the study, will be asked to identify the most suitable carer to participate in the study who could be approach in person, over the phone or by post as deemed suitable by the research team and convenient by the carer. Patient's permission to contact their identified carer will be recorded. Carers of consenting patients will be approached in the same manner as above after obtaining patients consent to contact their carers. Patients will still be able to take part in the study even if their carer declines consent.



Primary Outcome Measures :
  1. Investigation of lower temperatures of dialysis and cognitive decline [ Time Frame: 1.5 years ]
    To assess whether lower temperatures of dialysis fluid prevents the decline in cognitive function via utilisation of the Montreal Cognitive Assessment (MOCA) v7.2. The MOCA includes activities relating to Visuospatial / Executive (score out of 5); Naming (score out of 3); Memory (score of of 10); Attention (score out of 6); Naming (score out of 3) Abstraction (score out of 2); Delayed Recall (score out of 5) and Orientation (score out of 6). 1 point is given for each correct answer, and a higher score represents normal cognitive function, whilst lower scores represent possible cognitive decline. A total of 30 points can be achieved.


Secondary Outcome Measures :
  1. Frequency of intradialytic hypotension [ Time Frame: 1.5 years ]
    To measure the frequency of intradialytic hypotension as an explanatory outcome

  2. Recruitment rates [ Time Frame: 1.5 years ]
    To measure recruitment to inform the design of a larger clinical trial

  3. Attrition Rates [ Time Frame: 1.5 years ]
    To measure attrition rates to inform the design of a larger clinical trial

  4. Non-recruitment reasons [ Time Frame: 1.5 years ]
    To record reasons for non-recruitment and study attrition to inform the design of a larger clinical trial.

  5. Depression rates [ Time Frame: 1.5 years ]
    To measure depression in targeted population to be able to estimate exclusion rates of patients who would be suffering from "Depressive Pseudo Cognitive Impairment" from the future trial

  6. Outcomes from Burden questionnaire to assess burden in patients and carers [ Time Frame: 1.5 years ]
    To assess the burden of study-related interventions and assessments on patients and carers

  7. Cognitive battery outcome [ Time Frame: 1.5 years ]
    To assess the administration, suitability and adherence of the chosen cognitive method for patients, especially those from ethnic minorities

  8. Carers Burden assessment [ Time Frame: 1.5 years ]
    To assess the administration and suitability of the chosen method for measuring carers' burden in this group.

  9. Quality Of Life outcomes [ Time Frame: 1.5 years ]
    To assess the administration and suitability of the Assessment of Quality of Life 6 (AQoL-6) for quality of life measures and activities of daily living in haemodialysis participants. The AQoL-6 is a likert scale ranging from 'Never' (=1), 'Rarely' (=2) 'Some of the Time' (=3) 'Often' (=4) and 'Nearly All of the Time' (=5) - there are 20 items so a total score of 100 can be obtained. A score of 100 represents very poor quality of life, where as a score of 0 indicates very good quality of life.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is aged >18 years.
  2. Receiving haemodialysis three (3) times per week for ESKD, for at least 3 months
  3. Having proven mental capacity to understand the study and give informed consent

Exclusion Criteria:

  1. Established diagnosis of dementia in a memory clinic or specialised service.
  2. Receiving Acetylcholine Esterase Inhibitors
  3. Receiving antipsychotic or antidepressants unless stable on treatment for at least 6 weeks
  4. Current participation in a study of an investigational medicinal product
  5. Inter-current infection
  6. An operation date for a living donor kidney transplant within the period of the trial
  7. Patients expected to survive less than 1 year according to the treating nephrologist
  8. Patients prone to intra-dialytic hypotension or cardiovascular instability during haemodialysis according to the treating nephrologist
  9. Patients who are currently taking triptans, dopamine antagonists, tramadol, sedative and opioid analgesics
  10. Patients who have a known diagnosis or have other psychiatric conditions, including severe depression, bipolar affective disorder, severe anxiety, panic disorder, substance misuse or psychosis.
  11. Currently involved in another intervention study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645733


Contacts
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Contact: Liz Adey 0121 424 1123 elizabeth.adey@heartofengland.nhs.uk
Contact: Nick Denyer, MRes 0121 424 1633 nick.denyer@heartofengland.nhs.uk

Locations
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United Kingdom
Birmingham Heartlands Hospital Recruiting
Birmingham, West Midlands, United Kingdom, B9 5SS
Contact: Liz Adey         
Sponsors and Collaborators
Heart of England NHS Trust
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: George Tadros, MD University Hospitals Birmingham NHS Foundation Trust

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Responsible Party: Heart of England NHS Trust
ClinicalTrials.gov Identifier: NCT03645733    
Other Study ID Numbers: 2017054MH
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heart of England NHS Trust:
Haemodialysis
Kidney Disease
Mental Health
Cognitive Impairment
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dialysis Solutions
Pharmaceutical Solutions