Challenges Recruiting to a Study Investigating Extended Treatment Time on Haemodialysis Outcomes

Background: Outcomes on conventional haemodialysis (HD) remain suboptimal with observational data suggesting better survival with extended treatment times (TT). In the absence of prior trial data we studied the effect of extended TT on HD outcomes. Methods: Randomised cross-over study of in-centre HD patients with TT of either 6 hrs or 4 hrs for a period of 24 wks with a 4wk washout period between the two arms (NCT01721421). Assessments of nutritional status (malnutrition infl ammation score, bioimpedance analysis, hand grip), infl ammation and atherosclerosis (hs-CRP, MCP-1, BNP) are made before and after each treatment phase. Time to recovery is assessed and quality of life domains (KDQoL). Results: In total 634/725 (87%) patients screened met inclusion criteria 23 of these consented to date (21 male, mean age 58.7±12.9yrs), a recruitment rate of 4%. Reasons cited by patients for refusing consent include inability to sit for long periods and commitments as carers to partners & family and anxiety that the shorter control TT (for those whose pre study TT>4) may be detrimental. 60% of nursing staff questioned felt extended TT was beneficial with 36% reporting it well tolerated. Nonetheless just 38% would recommend extended TT to patients with 66% stating it affected service provision. Conclusions: Enrolled patients tolerate extended treatment times well but there is a significant impact on in-centre HD provision. Staff attitudes may impact on enrolment in similar trials and must be addressed. Extended TT maybe more pragmatic in domiciliary or nocturnal HD services.