While hemodialysis is a life-saving procedure for many people living with kidney failure, it is far from perfect. Hemodialysis patients often deal with difficult symptoms and are still at increased risk of mortality. Dr. Claire Harris, a nephrologist and Medical Director of the Vancouver General Hospital Hemodialysis Unit, is working to change the status quo. Her research focuses on improving hemodialysis care via pragmatic clinical trials, which enable important research questions and novel solutions to be explored more easily across large patient populations.
Harris notes that although there have been some advances in dialysis technology, survival rates of hemodialysis patients have plateaued since the early 2000s, and few interventions have successfully improved their quality of life. “It's not for lack of effort,” she emphasizes.
A key challenge has been the sheer amount of resources needed to run a research study, which involves recruiting many patients, gaining ethics approval, getting individual consent from patients, and so much more. “It’s difficult to get large groups of patients, because it's going to take so much effort, so much money, so much research assistance to actually get it done,” Harris explains.
To overcome these barriers, Harris has been working with Ontario-based nephrologist Dr. Amit Garg and dozens of other nephrologists across the country to launch a pragmatic clinical trials network. Their goal is to identify research questions, in collaboration with patient partners, that have potential to be highly impactful, and can easily be investigated in the hemodialysis clinic setting. Through cluster randomized trials, some clinics will get one intervention, and others will get a different one. Importantly, the researchers are able to do these studies without filling out 20+ page consent forms for each individual patient, but more simply inform patients of the study and answer any questions they may have.
This past March, the network concluded one of its first pragmatic trials, where Harris was the BC principal investigator overseeing its implementation throughout much of the province. The four-year trial looked at how different concentrations of dialysate magnesium impacts patients in terms of mortality, cardiovascular outcomes, and muscle cramps.
“We had more than 2,000 patients from BC involved,” says Harris, adding that patient partners also helped oversee the trial design. “It was exciting to show that we could do something across the whole province, including in rural dialysis units.”
While data from the massive study – spanning more than 150 hemodialysis clinics across four provinces – are still being analyzed, Harris notes that this study sets the stage for similar, large-scale studies to take place in the future.
“We have a better idea of how to do it, how to get over the barriers, and how to do the ethics across BC. So I think it's really broken down a lot of barriers for future trials,” she says, adding, “And I think people have found it generally rewarding to be involved.”
