During his training as a nephrologist, Dr. Ron Wald became interested in conducting clinical trials to determine the best way to treat patients with severe kidney problems.
Acute kidney injury refers to the abrupt decline of the kidneys’ ability to function, which leads to the buildup of fluid, electrolytes, acid and other toxins. It is common among patients admitted to intensive care units, especially those with severe infections or after cardiac and vascular surgery.
“As a nephrologist in a busy tertiary care hospital, acute kidney injury is one of the most common reasons why I am asked for consultation,” says Dr. Wald. “Each year, about 100 St. Michael’s patients go on acute dialysis because of AKI.”
For patients who experience acute kidney injury and require dialysis, the 30-day mortality rate is a staggering 50 to 60 per cent.
There are many areas of controversy about how dialysis should be administered to patients with acute kidney injury. One of these relates to the best time to start dialysis in patients with acute kidney injury. And that’s where Dr. Wald’s research comes in.
Dr. Wald is conducting a 100-patient pilot randomized, controlled trial to test which approach to dialysis is more effective – early, pre-emptive dialysis vs. reserving dialysis for patients when they absolutely need it.
Recruitment for the pilot trial is about 80 per cent complete.
“We expect the first results will likely be available in the fall and that we will be able to publish by the end of the year,” Dr. Wald said.
A random sample of patients will be assigned to each treatment from 12 academic health sciences centres across Canada, including St. Michael’s Hospital; The Ottawa Hospital – both the General and Civic campuses; University Health Network – Toronto General and Toronto Western sites; Sunnybrook Health Sciences Centre; Mt. Sinai Hospital; St. Joseph’s Health Care Hamilton; London Health Sciences Centre – Victoria and University hospitals; University of Alberta Hospital; and Sherbrooke University Hospital Centre.
Once the protocol has been tested in the pilot, the goal will be to conduct a much larger trial that will address whether the timing of dialysis has an impact on mortality rates. At this point, Dr. Wald expects to be applying for research funding in 2014 to conduct the larger trial.
The trial is also benefiting from the expert management of the Applied Health Research Centre, which is based at St. Michael’s. AHRC provides comprehensive research services, including coordination of clinical trials (Phase II-IV), observational research, epidemiological research, qualitative studies, patient registries, financial and contract management, biostatistical and methodological support and industry-leading IT.
“During the pilot, we are also testing our ability to ensure consistency and quality across multiple centres,” Dr. Wald said. “This is particularly important as we look at running an international trial that will involve thousands of patients in the next stage.”
Dr. Wald is also studying the impact of acute kidney injury on long-term outcomes using Ontario-wide data. Research shows that a substantial proportion of patients with acute kidney injury end up with chronic irreversible kidney disease. He is conducting research to determine whether long-term kidney function can be affected by the way in which acute kidney injury is treated at the outset.