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.
Cognition
Cognitive function
Cold temperature
Haemodialysis
Haemodialysis solutions
Randomised controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
30 Sep 2020
30 Sep 2020
Historique:
received:
11
05
2020
accepted:
03
09
2020
entrez:
1
10
2020
pubmed:
2
10
2020
medline:
22
6
2021
Statut:
epublish
Résumé
Cognitive impairment is common in haemodialysis (HD) patients and is associated independently with depression and mortality. This association is poorly understood, and no intervention is proven to slow cognitive decline. There is evidence that cooler dialysis fluid (dialysate) may slow white matter changes in the brain, but no study has investigated the effect of cooler dialysate on cognition. This study addresses whether cooler dialysate can prevent the decline in cognition and improve quality of life (QOL) in HD patients. This is a multi-site prospective randomised, double-blinded feasibility trial. Four HD units in the UK. Ninety HD patients randomised (1:1) to standard care (dialysate temperature 36.5 °C) or intervention (dialysate temperature 35 °C) for 12 months. Change in cognition using the Montreal Cognitive Assessment (MoCA). Recruitment and attrition rates, reasons for non-recruitment, frequency of intradialytic hypotension, depressive symptom scores, patient and carers burden, a detailed computerised cognitive test and QOL assessments. mixed method approach, utilising measurement of cognition, questionnaires, physiological measurements and semi-structured interviews. The results of this feasibility trial will inform the design of a future adequately powered substantive trial investigating the effect of dialysate cooling on prevention and/or slowing in cognitive decline in patients undergoing haemodialysis using a computerised battery of neuro-cognitive tests. 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 1 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. ClinicalTrials.gov NCT03645733 . Registered retrospectively on 24 August 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Cognitive impairment is common in haemodialysis (HD) patients and is associated independently with depression and mortality. This association is poorly understood, and no intervention is proven to slow cognitive decline. There is evidence that cooler dialysis fluid (dialysate) may slow white matter changes in the brain, but no study has investigated the effect of cooler dialysate on cognition. This study addresses whether cooler dialysate can prevent the decline in cognition and improve quality of life (QOL) in HD patients.
METHODS
METHODS
This is a multi-site prospective randomised, double-blinded feasibility trial.
SETTING
METHODS
Four HD units in the UK.
PARTICIPANTS AND INTERVENTIONS
METHODS
Ninety HD patients randomised (1:1) to standard care (dialysate temperature 36.5 °C) or intervention (dialysate temperature 35 °C) for 12 months.
PRIMARY OUTCOME MEASURE
METHODS
Change in cognition using the Montreal Cognitive Assessment (MoCA).
SECONDARY OUTCOME MEASURES
METHODS
Recruitment and attrition rates, reasons for non-recruitment, frequency of intradialytic hypotension, depressive symptom scores, patient and carers burden, a detailed computerised cognitive test and QOL assessments.
ANALYSIS
METHODS
mixed method approach, utilising measurement of cognition, questionnaires, physiological measurements and semi-structured interviews.
DISCUSSION
CONCLUSIONS
The results of this feasibility trial will inform the design of a future adequately powered substantive trial investigating the effect of dialysate cooling on prevention and/or slowing in cognitive decline in patients undergoing haemodialysis using a computerised battery of neuro-cognitive tests. 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 1 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 REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT03645733 . Registered retrospectively on 24 August 2018.
Identifiants
pubmed: 32998761
doi: 10.1186/s13063-020-04725-0
pii: 10.1186/s13063-020-04725-0
pmc: PMC7526411
doi:
Banques de données
ClinicalTrials.gov
['NCT03645733']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
820Subventions
Organisme : Department of Health
ID : PB-PG-1215-20008
Pays : United Kingdom
Organisme : Research for Patient Benefit Programme
ID : PB-PG-1215-20008
Références
Nephron Clin Pract. 2014;128(1-2):39-44
pubmed: 25342115
World J Nephrol. 2016 Mar 6;5(2):166-71
pubmed: 26981441
Am J Kidney Dis. 2005 Apr;45(4 Suppl 3):S1-153
pubmed: 15806502
Nephron Clin Pract. 2014;128(3-4):303-11
pubmed: 25531673
Eval Health Prof. 1993 Jun;16(2):205-11
pubmed: 10171430
Proc Eur Dial Transplant Assoc. 1981;18:597-602
pubmed: 7329988
PLoS One. 2014 Oct 27;9(10):e106700
pubmed: 25347578
J Am Geriatr Soc. 2008 May;56(5):823-30
pubmed: 18384586
Nephrol Dial Transplant. 2013 Jul;28(7):1810-9
pubmed: 23166308
Am J Kidney Dis. 2010 Oct;56(4):693-703
pubmed: 20800327
Blood Purif. 2018;45(4):347-355
pubmed: 29455207
J Cereb Blood Flow Metab. 2007 Nov;27(11):1861-9
pubmed: 17406658
Qual Life Res. 1999 May;8(3):209-24
pubmed: 10472152
Clin J Am Soc Nephrol. 2016 Mar 7;11(3):442-57
pubmed: 26712807
Kidney Int. 2014 Mar;85(3):505-7
pubmed: 24583984
Am J Kidney Dis. 2014 Jul;64(1):86-94
pubmed: 24529994
Semin Nephrol. 2015 Jul;35(4):304-10
pubmed: 26355249
Nat Rev Nephrol. 2015 Dec;11(12):707-19
pubmed: 26281892
J Am Soc Nephrol. 2017 Apr;28(4):1269-1277
pubmed: 28122851
J Psychosom Res. 2002 Feb;52(2):69-77
pubmed: 11832252
Nephrol Dial Transplant. 2015 Oct;30(10):1699-705
pubmed: 26175142
Neurology. 2014 Mar 25;82(12):1051-7
pubmed: 24553427
Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii5-21
pubmed: 17507427
Acta Psychiatr Scand. 1983 Jun;67(6):361-70
pubmed: 6880820
Semin Dial. 2016 Nov;29(6):435-441
pubmed: 27556272
J Am Soc Nephrol. 2005 Jul;16(7):2127-33
pubmed: 15888561
Clin J Am Soc Nephrol. 2014 Dec 5;9(12):2124-32
pubmed: 25376764
Kidney Int. 2006 Sep;70(5):956-62
pubmed: 16837916
Nephrol Dial Transplant. 2005 Sep;20(9):1784-9
pubmed: 15998656
Am J Prev Med. 2009 May;36(5):452-7
pubmed: 19362699
Clin J Am Soc Nephrol. 2015 Aug 7;10(8):1408-17
pubmed: 25964310
J Am Soc Nephrol. 2015 Apr;26(4):957-65
pubmed: 25234925
Age Ageing. 1996 Mar;25(2):113-20
pubmed: 8670538
Clin J Am Soc Nephrol. 2015 Aug 7;10(8):1318-20
pubmed: 26195504
J Am Geriatr Soc. 2005 Apr;53(4):695-9
pubmed: 15817019
J Eval Clin Pract. 2004 May;10(2):307-12
pubmed: 15189396
Am J Kidney Dis. 2007 Aug;50(2):270-8
pubmed: 17660028
Clin J Am Soc Nephrol. 2009 Jan;4(1):93-8
pubmed: 18842948
J Am Soc Nephrol. 2016 Mar;27(3):715-21
pubmed: 26251352
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
Neurology. 2006 Jul 25;67(2):216-23
pubmed: 16864811
N Engl J Med. 2010 Dec 9;363(24):2287-300
pubmed: 21091062
J Am Soc Nephrol. 2015 Mar;26(3):724-34
pubmed: 25270068
J Am Soc Nephrol. 2017 Aug;28(8):2511-2520
pubmed: 28270412
Arch Clin Neuropsychol. 2009 Mar;24(2):165-78
pubmed: 19395350
Hemodial Int. 2015 Oct;19(4):543-52
pubmed: 25952255