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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.

ABSTRACT: 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:This is a multi-site prospective randomised, double-blinded feasibility trial. SETTING:Four HD units in the UK. PARTICIPANTS AND INTERVENTIONS: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:Change in cognition using the Montreal Cognitive Assessment (MoCA). SECONDARY OUTCOME MEASURES: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:mixed method approach, utilising measurement of cognition, questionnaires, physiological measurements and semi-structured interviews. DISCUSSION: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:ClinicalTrials.gov NCT03645733 . Registered retrospectively on 24 August 2018.

SUBMITTER: Dasgupta I

PROVIDER: S-EPMC7526411 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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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.

Dasgupta Indranil I Odudu Aghogho A Baharani Jyoti J Fergusson Niall N Griffiths Helen H Harrison John J Maruff Paul P Thomas G Neil GN Woodhall Gavin G Youseff Samir S Tadros George G

Trials 20200930 1

<h4>Background</h4>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 a ...[more]

PMID: 32998761

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Project description:BackgroundEnd-stage kidney disease is a life-changing illness. Many patients require haemodialysis, a treatment that impacts profoundly on quality of life and mental health. Arts-based interventions have been used in other healthcare settings to improve mental health and quality of life; therefore, they may help address the impact of haemodialysis by improving these outcomes. However, there is a lack of evidence assessing their effectiveness in this population and few randomised controlled trials (RCTs) evaluating the effectiveness of complex arts-based interventions.MethodsThe aims of this study are to establish the feasibility of a cluster RCT of an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis through a cluster randomised pilot study, explore the acceptability of the intervention with a process evaluation and explore the feasibility of an economic evaluation. The study will have three phases. The first phase consists of a cluster randomised pilot study to establish recruitment, participation and retention rates. This will involve the recruitment of 30 participants who will be randomly allocated through cluster randomisation according to shift pattern to experimental and control group. The second phase will be a qualitative process evaluation to establish the acceptability of the intervention within a clinical setting. This will involve semi-structured interviews with 13 patients and three focus groups with healthcare professionals. The third phase will be a feasibility economic evaluation to establish the best methods for data collection within a future cluster RCT.DiscussionArts-based interventions have been shown to improve quality of life in healthcare settings, but there is a lack of evidence evaluating arts-based interventions for patients receiving haemodialysis. This study aims to assess the feasibility of a future cluster RCT assessing the impact of an arts-based intervention on the wellbeing and mental health of patients receiving haemodialysis and identify the key factors leading to successful implementation. The hope is this study will inform a trial that can influence future healthcare policy by providing robust evidence for arts-based interventions within the haemodialysis setting.Trial registrationThe trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496.

Project description:BackgroundFrailty is a state of low physiological reserve and multi-systemic dysregulation that leads to susceptibility to external stressors; it is associated with adverse outcomes. North American data suggest that haemodialysis recipients are more likely to be frail than the general population, although data on UK cohorts are lacking. Furthermore, with a multitude of assessment tools, it is difficult for the clinician to ascertain which is most suitable for this population. The FITNESS Study aims to measure the prevalence and outcomes associated with frailty in a large UK haemodialysis cohort to determine the optimum frailty tool as defined by predictive value for mortality/hospitalisation and to conduct a feasibility study exploring a multi-disciplinary clinical intervention to improve frailty among haemodialysis recipients.Methods/designThe study will follow a cohort multiple randomised controlled trial design; the initial cohort study will identify participants to be invited into a subsequent open-label randomised controlled trial. Eligible patients will be identified and recruited from their usual haemodialysis session. They will be invited to complete tasks and questionnaires collecting data on sarcopenia, immunosenescence, mood, cognition, disability, and comorbidity. Fifty pre-frail participants with suitable English proficiency will be randomly selected from this cohort to participate in the randomised controlled trial phase of the study. Further stratified randomisation will occur to assign these 50 participants to active or passive groups. The active group will receive a psychologically supported, patient-centred, multi-disciplinary intervention into frailty, in what we believe to be a first within this patient group. The control group will receive usual haemodialysis standard of care. All participants will be followed up using electronic patient records for outcomes to include hospitalisation and mortality. Primary outcomes for this phase of the study will be feasibility and tolerability of the clinical intervention study.DiscussionThe study will collect data on multiple aspects of frailty allowing for a rich dataset for detailed analysis. We believe this will be the first study to explore a psychologically supported, patient-centred intervention in this patient group.Trial registrationClinicaltrials.gov, NCT03071107 . Registered on 6 March 2017.

Project description:BackgroundPatients with end-stage kidney disease, receiving haemodialysis rely increasingly on informal carers to help manage their debilitating chronic disease. Informal carers may experience a negative impact on their quality of life exacting a toll on their physical, social and emotional well-being. Informal carers of patients with end-stage kidney disease receiving haemodialysis have significant unmet needs which may include physical and psychological issues, financial disadvantage and social isolation. Poor experiences of informal carers may also impact the experience of the patients for whom they care. The needs of this group of informal caregivers have been largely neglected, with little emphasis placed on supportive interventions that might assist and support them in their caring role. The aim of this study is therefore to explore the experiences and unmet needs of informal carers of people with end-stage kidney disease receiving haemodialysis and develop a psychosocial intervention to support them in their caring role.MethodsThis qualitative study will include a systematic review, semi-structured interviews with 30 informal carers and focus groups with renal health care professionals. Perceptions of care provision, caregiving experiences as well as contextual factors impacting the design and delivery of a psychosocial intervention for informal carers of patients with end-stage kidney disease, will be explored and will inform the development of a supportive intervention.DiscussionThe needs of informal carers of patients with end-stage kidney disease have been neglected with little emphasis placed on supportive interventions that might assist and support this group in their care giving role. This is in contrast to other chronic disease groups such as stroke, cancer and dementia. In these conditions well developed supportive interventions have significantly improved outcomes in regard to informal caregivers' preparedness, competence, positive emotions and psychological well-being in terms of informal care provision. Support interventions could potentially improve the quality of life of those informal carers who provide care to patients with end-stage kidney disease receiving haemodialysis.

Project description:IntroductionHaemodialysis (HD) is the cornerstone treatment for patients with end-stage renal disease (ESRD). However, highly protein bound or large molecular weight uremic toxins such as phenolic and indolic compounds and homocysteine, which are associated with adverse outcomes such as cardiovascular disease of patients with ESRD, are difficult to remove via HD but can be effectively eliminates by haemoperfusion (HP). The proposed trial (referred to as HD/HP vs HD below) is a randomised, open-label, multicentre trial comparing HD plus HP versus HD alone in adult patients with ESRD. The primary endpoint measure is all-cause mortality.Methods and analysisWe plan to enrol 1364 maintenance HD patients from 11 medical centres in Shanghai. Participants will be randomised to receive HD plus HP or HD alone at a 1:1 ratio after 1-month run-in period. In both arms, patients will receive low-flux HD at a frequency of two times a week and haemodiafiltration at a frequency of once a week. In the intervention group, subjects also received HP once every 2 weeks. Follow-up is scheduled at 3, 6, 12, 18 and 24 months after randomisation, and will consist the following: routine physical examinations, standard lab panels (blood routine, liver/residual kidney functions, tests of the coagulation system, etc), dialysis adequacy (standard Kt/V), chest X-ray, ECG, echocardiography, heart function rating. Adverse events will be assessed according to the international conference on harmonisation guidelines. The primary outcome is 24-month all-cause mortality. Secondary outcomes will include cardiovascular-related mortality, the occurrence of major cardiovascular events and the quality of life.Ethics and disseminationThe study protocol has been approved by the Ethical Committees of all 11 participating centres. Clinical Research Unit of Xin Hua Hospital will oversee the study. The results will be presented at national and international academic meetings, and submitted to peer-reviewed journals for publications.Trial registration numberNCT03227770; Pre-results.

Project description:BackgroundShort-daily haemodialysis (SDH) has been strongly recommended over conventional haemodialysis (CHD) for end-stage kidney disease patients, though few studies have directly compared the effects of these two haemodialysis (HD) modalities on clinical variables related to patient's health.MethodsWe conducted a cross-sectional study in individuals undergoing HD, comparing epidemiological, clinical, metabolic, inflammatory, anthropometric, bone health/metabolism, and skeletal muscle function according to dialysis modality. One-hundred seventy-eight patients (20.8% females, 62 ± 2.5 years old), were analysed in this study, 86 (48%) of whom were undergoing CHD versus 92 (51%) who were undergoing SDH.ResultsSDH patients had significantly higher serum albumin levels (3.93 vs. 3.66 g/dL, P < 0.0001) and higher Kt/v (2.6 vs. 2.38, P < 0.0001). SDH group presented a significantly lower number of erythropoietin-stimulating agents compared with CHD group (percentage: 53.3 vs. 83.7%, P < 0.0001) and had lower levels of serum phosphate (4.9 vs. 5.3 mg/dL, P = 0.004) and parathyroid hormone (PTH) (398.4 vs. 480.4 pg/mL, P < 0.001) compared with CHD patients. In terms of bone health and metabolism, SDH patients had significantly higher total BMD, femur BMD, lumbar BMD, and femoral neck BMD compared with CHD patients (all P < 0.05). SDH patients also had lower anti-osteogenic and inflammatory biomarkers, including FGF23, sclerostin, TNF, IL-18, IL-17a, and C-reactive peptide (all P < 0.05). CHD modality was demonstrated to be a risk factor for low BMD (odds ratio: 4.02; 95% CI: 1.59-10.2, P = 0.003). In terms of skeletal muscle function, SDH patients had significantly higher 6-minute walking test (444.6 vs. 424.9 m, P = 0.04) and higher fat-free mass (52.3 vs. 51.68 kg, P = 0.02) compared with CHD patients. Higher fat-free mass and handgrip strength were associated with a 34% and 23% lower risk of low BMD, respectively. SDH patients had lower levels of the uremic toxin asymmetric dimethyl-l-arginine (ADMA) (1.8 vs. 2.07 μM, P = 0.002) and fasting blood glucose (132.6 vs. 141.7 mg/dL, P < 0.02) than CHD group. SDH patients also displayed higher levels of haemoglobin when compared with CHD group (11.9 vs. 10.2 g/dL, P < 0.0001).ConclusionsThe present study improves our understanding of the relationship between dialysis modality and clinical variables that may influence HD patient's health. Grip strength and lean mass were positively correlated with bone mineral density in HD patients regardless of dialysis modality. SDH was associated with better bone mineral density, inflammatory profile, and skeletal muscle function when compared with CHD patients. These findings provide more evidence of the clinical benefits of SDH that should be explored in greater detail.

Dataset Information

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.

Publications

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.

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