Table 5 TiME: increased haemodialysis duration session

Patient selection criteria

“Inclusion criteria for patients were (1) age ≥18 years, (2) treatment with thrice-weekly in-center hemodialysis, and (3) initiation of dialysis within the previous 120 days. Exclusion criteria for patients were (1) use of a health care proxy to provide consent for dialysis treatment and (2) unwillingness to have clinical data included in the trial dataset.”

Randomisation

“Dialysis facilities were randomised 1:1 to the intervention or the usual care group, using a permuted block randomisation procedure with stratification by dialysis provider organization, and by factors known to be associated with mortality: racial composition (≤50% or >50% black patients) and use of central venous catheters for hemodialysis vascular access (≤20% or >20% of patients).”

Compliance

“Participant follow-up ended on January 31, 2017 on the basis of the recommendation by the DSMB to terminate the trial because of a lower than anticipated difference in session duration between the intervention and usual care groups (…).”

“For the primary analysis population, the estimated mean prescribed session duration was 219 (95% confidence interval [95% CI], 217 to 222) minutes in the intervention group and 210 (95% CI, 209 to 213) minutes in the usual care group.”

“Discussions with facility staff and medical directors during the course of the trial indicated that the major reasons for poor uptake of the intervention were unwillingness by patients to have longer dialysis treatments, perception by the treating nephrologists that longer dialysis was not needed because of adequate solute clearance, and perception by the treating nephrologists that longer session durations were not in the best interest of a patient because of older age and/or frailty.”