NCT03645733

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

August 7, 2018

Last Update Submit

February 10, 2020

Conditions

Cognitive Impairment

Keywords

HaemodialysisKidney DiseaseMental HealthCognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Investigation of lower temperatures of dialysis and cognitive decline

    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.

    1.5 years

Secondary Outcomes (9)

  • Frequency of intradialytic hypotension

    1.5 years

  • Recruitment rates

    1.5 years

  • Attrition Rates

    1.5 years

  • Non-recruitment reasons

    1.5 years

  • Depression rates

    1.5 years

  • +4 more secondary outcomes

Study Arms (3)

Control Group

NO INTERVENTION

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

Lower Temperature Group

EXPERIMENTAL

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

Caregivers

NO INTERVENTION

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.

Interventions

Lower Temperature GroupPROCEDURE

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.

Lower Temperature Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Established diagnosis of dementia in a memory clinic or specialised service.
  • Receiving Acetylcholine Esterase Inhibitors
  • Receiving antipsychotic or antidepressants unless stable on treatment for at least 6 weeks
  • Current participation in a study of an investigational medicinal product
  • Inter-current infection
  • An operation date for a living donor kidney transplant within the period of the trial
  • Patients expected to survive less than 1 year according to the treating nephrologist
  • Patients prone to intra-dialytic hypotension or cardiovascular instability during haemodialysis according to the treating nephrologist
  • Patients who are currently taking triptans, dopamine antagonists, tramadol, sedative and opioid analgesics
  • 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.
  • Currently involved in another intervention study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birmingham Heartlands Hospital

Birmingham, West Midlands, B9 5SS, United Kingdom

RECRUITING

Related Publications (3)

  • Dasgupta I, Odudu A, Baharani J, Fergusson N, Griffiths H, Harrison J, Hameed A, Maruff P, Ryan L, Thomas N, Woodhall G, Tadros G. Evaluation of effect of cooled haemodialysis on cognition in patients with end-stage kidney disease (ECHECKED) feasibility randomised controlled trial results. BMC Nephrol. 2024 Dec 19;25(1):466. doi: 10.1186/s12882-024-03883-6.

    PMID: 39702060DERIVED

  • Kulkarni M, Prabhu AR, Rao IR, Nagaraju SP. Interventions for preventing haemodialysis dysequilibrium syndrome. Cochrane Database Syst Rev. 2024 May 22;5(5):CD015526. doi: 10.1002/14651858.CD015526.pub2.

    PMID: 38775299DERIVED

  • Dasgupta I, Odudu A, Baharani J, Fergusson N, Griffiths H, Harrison J, Maruff P, Thomas GN, Woodhall G, Youseff S, Tadros G. Evaluation of the effect of Cooled HaEmodialysis on Cognitive function in patients suffering with end-stage KidnEy Disease (E-CHECKED): feasibility randomised control trial protocol. Trials. 2020 Sep 30;21(1):820. doi: 10.1186/s13063-020-04725-0.

    PMID: 32998761DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionKidney DiseasesPsychological Well-Being

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPersonal SatisfactionBehavior

Study Officials

  • George Tadros, MD

    University Hospital Birmingham NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liz Adey

CONTACT

0121 424 1123elizabeth.adey@heartofengland.nhs.uk

Nick Denyer, MRes

CONTACT

0121 424 1633nick.denyer@heartofengland.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
One nurse, that gives the patients their cognitive questionnaire battery, is masked from knowing which dialysis fluid temperature the patient is receiving.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 24, 2018

Study Start

December 20, 2017

Primary Completion

October 31, 2019

Study Completion

October 31, 2020

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)