News: Royal Free London recruits patients to RESOLVE study

The Royal Free London NHS Foundation Trust has recruited patients receiving dialysis to a trial investigating the comparative effectiveness of two dialysate sodium concentrations.

Currently, sodium levels in dialysate vary from 135 to 141 mmol/L. Despite improvements in the technology, many people receiving dialysis suffer sodium and fluid overload, resulting in high blood pressure and cardiovascular disease. Lowering dialysate sodium, however, can result in harm from unstable blood pressure. The RESOLVE study will provide a better understanding of how different concentrations affect patient outcomes.

Four dialysis units at the trust have each been randomly assigned to use dialysate sodium concentrations of either 137 or 140 mmol/L for most dialysis sessions. Patients receiving treatment at the units are included in the study, unless they opt out of data collection. The study aims to track the health of approximately 56,000 participants recruited at sites around the world. It is estimated that results will be available in four years’ time.

Commenting on the opt-out model of consent, Professor David Wheeler (Chief Investigator for the UK study) noted that “the majority of dialysis patients are happy for data that we collect routinely for audit purposes to be used for research that may improve patient outcomes.” Co-investigator Rani Badhan added that a patient advisory group had helped to ensure that the recruitment strategy for the UK “is acceptable and inclusive to patients from all backgrounds.”

It is anticipated that once it has been determined which dialysate sodium concentration provides the better outcomes, all patients will switch to that level, unless there is no difference between the two.