Preserving residual kidney function (RKF) may be beneficial to patients on haemodialysis (HD) and it has been proposed that commencing dialysis incrementally rather than three times a week may preserve RKF. In Incremental HD, target dose includes a contribution from RKF, which is added to HD dose, allowing individualisation of the HD prescription. We will conduct a feasibility randomised controlled trial (RCT) comparing incremental HD and conventional three times weekly treatments in incident HD patients. The study is designed also to provide pilot data to allow determination of effect size to power a definitive study.
After screening to ensure native renal urea clearance >3 mL/min/1.73 m2, the study will randomise 54 patients within 3 months of HD initiation to conventional in-centre thrice weekly dialysis or incremental in-centre HD commencing 2 days a week. Subjects will be followed up for 12 months. The study will be carried out across four UK renal centres.
The primary outcome is to evaluate the feasibility of conducting a definitive RCT and to estimate the difference in rate of decline of RKF between the two groups at 6 and 12 months time points. Secondary outcomes will include the impact of dialysis intensity on vascular access events, major adverse cardiac events and survival. Impact of dialysis intensity on patient-reported outcomes measures, cognition and frailty will be assessed using EQ-5D-5L, PHQ-9, Illness Intrusiveness Rating Score, Montreal Cognitive assessment and Clinical Frailty Score. Safety outcomes include hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events.
This study will inform the design of a definitive study, adequately powered to determine whether RKF is better preserved after incremental HD initiation compared with conventional initiation.
Ethics approval has been granted by Cambridge South Research Ethics Committee, United Kingdom(REC17/EE/0311). Results will be disseminated via peer-reviewed publication.
Iodinated contrast media are commonly used in medical imaging and can cause hypersensitivity reactions, including rare but severe life-threatening reactions. Although several prophylactic approaches have been proposed for severe reactions, their effects remain unclear. Therefore, we aim to review systematically the preventive effects of pharmacologic and non-pharmacologic interventions and predictors of acute, hypersensitivity reactions.
We will search the PubMed, EMBASE and Cochrane Central Register of Controlled Trials databases from 1 January 1990 through 31 December 2019 and will examine the bibliographies of eligible studies, pertinent review articles and clinical practice guidelines. We will include prospective and retrospective studies of any design that evaluated the effects of pharmacological and non-pharmacological preventive interventions for adverse reactions of non-ionic iodinated contrast media. Two assessors will independently extract the characteristics of the study and intervention and the quantitative results. Two independent reviewers will assess the risk of bias using standard design-specific validity assessment tools. The primary outcome will be reduction in acute contrast media-induced hypersensitivity reactions. The secondary outcomes will include characteristics associated with the development of contrast media-induced acute hypersensitivity reactions, and adverse events associated with specific preventive interventions. Unique premedication regimens (eg, dose, drug and duration) and non-pharmacological strategies will be analysed separately. Average-risk and high-risk patients will be considered separately. A meta-analysis will be performed if appropriate.
Ethics approval is not applicable, as this will be a secondary analysis of publicly available data. The results of the analysis will be submitted for publication in a peer reviewed journal.
End-stage kidney disease (ESKD) is a major public health problem affecting more than 2 million people worldwide. It is one of the most severe chronic non-communicable diseases. Haemodialysis (HD) is the most common therapeutic option but is also associated with a risk of cardiovascular events, hospitalisation and suboptimal quality of life. Over the past decades, haemodiafiltration (HDF) has become available. Although high-dose HDF has shown some promising survival advantage compared to conventional HD, the evidence remains controversial. A Cochrane systematic review found, in low-quality trials, with various convective forms of dialysis, a reduction in cardiovascular, but not all-cause mortality and the effects on non-fatal cardiovascular events and hospitalisation were uncertain. In contrast, an individual patient data analysis suggested that high-dose HDF reduced both all-cause and cardiovascular mortality compared to HD. In view of these discrepant results, a definitive trial is required to determine whether high-dose HDF is preferable to high-flux HD. The comparison of high-dose HDF with high-flux HD (CONVINCE) study will assess the benefits and harms of high-dose HDF versus a conventional high-flux HD in adults with ESKD.
This international, prospective, open label, randomised controlled trial aims to recruit 1800 ESKD adults treated with HD in nine European countries. Patients will be randomised 1:1 to high-dose HDF versus continuation of conventional high-flux HD. The primary outcome will be all-cause mortality at 3 years’ follow-up. Secondary outcomes will include cause-specific mortality, cardiovascular events, all-cause and infection-related hospitalisations, patient-reported outcomes (eg, health-related quality of life) and cost-effectiveness.
The CONVINCE study will address the question of benefits and harms of high-dose HDF compared to high-flux HD for kidney replacement therapy in patients with ESKD with a focus on survival, patient perspectives and cost-effectiveness.
Netherlands National Trial Register (NTR 7138).
End-stage kidney disease disproportionately affects people of South Asian origin. This study aimed to uncover the lived experiences of this group of patients on centre-based haemodialysis (HD), the most prevalent dialysis modality.
The study utilised a qualitative focus group methodology. Seven focus groups were conducted across four NHS Trusts in the UK including three in Gujarati and two each in Punjabi and Urdu. This provided an inclusive opportunity for South Asian patients to contribute in their language of origin. A total of 24 patients participated. Focus groups were facilitated by bilingual project workers and data were forward translated and analysed using thematic analysis.
Four themes were identified. This included (1) ‘treatment imposition’, which comprised of the restrictive nature of HD, the effects of treatment and the feeling of being trapped in an endless process. (2) The ‘patient–clinician relationship’ centred around the impact of a perceived lack of staff time, and inadequacies in the quality of interactions. (3) ‘Coping strategies’ highlighted the role of cognitive reappraisal, living in the moment and family support networks in facilitating adjustment. (4) ‘Pursuit of transplantation’ included equating this form of treatment with restoring normality, alongside cultural factors limiting hopefulness for receiving an organ.
In general, the experiences of South Asian patients receiving HD were not unique to this ethnic group. We did find distinct issues in relation to interactions with healthcare professionals, views on access to transplantation and the importance of family support networks. The study provides useful insights which may help enhance culturally tailored renal care.