Photo caption: Dr. Shannon Fernando, Principal Investigator for the BLUSH study at Lakeridge Health, celebrates the site’s first Health Canada–approved investigator‑led trial (photo credit: Kolter Bouchard, Symal Creative Inc.)
Lakeridge Health has reached a significant milestone with the launch of its first Health Canada investigator-led study, the ‘BLUSH’ trial, evaluating adjunctive methylene blue in septic shock. Developed and launched at Lakeridge Health, the study reflects the growing capacity of community hospitals to lead high-quality clinical research that addresses pressing clinical questions. While currently operating as a single-site study, there are plans to expand to a multi-centre trial in the near future.
Investigator-led trials are often associated with academic centres, yet this work demonstrates that community hospitals can successfully design, obtain regulatory approval for, and execute rigorous clinical studies.
“This study represents an important evolution in how research is conducted,” says Dr. Shannon Fernando, Research Lead, Department of Critical Care and Medical Director, Trauma Program, Lakeridge Health. “With the right infrastructure and clinical leadership, community hospitals can move ideas from concept to implementation while meeting Health Canada standards.”
The BLUSH study is grounded in a clear clinical rationale. Sepsis remains a leading cause of death globally, with mortality rates approaching 40 per cent in patients with septic shock, and treatment guidance has seen limited change in recent years. Methylene blue is being evaluated as an adjunctive therapy in septic shock, with the study designed to assess its effects within the critical care setting. The therapy itself is low-cost and widely available. If shown to be effective, this approach could help broaden treatment options across diverse care settings, including more remote or resource-limited sites, where access to advanced intensive care technologies may be limited.
Since opening to enrollment in June 2025, the study has demonstrated strong recruitment momentum. By mid January 2026, 38 Intensive Care Unit (ICU) patients had already been enrolled, reflecting both the clinical relevance of the research question, community interest, and strength of local research infrastructure to support time-sensitive critical care studies.
Launching BLUSH required close coordination across research administration, pharmacy, nursing, laboratory services, and critical care. Central to this effort were a dedicated study startup team and ICU research champions, whose combined administrative and clinical leadership supported regulatory submissions, staff training, and adherence to Health Canada requirements. This integrated model enabled efficient study activation while maintaining patient safety and protocol fidelity in a high-acuity environment.
The study also reflects a patient-centred approach to research. Patients receiving care at Lakeridge Health are able to participate in a locally developed clinical trial without the need to travel to large academic centres. “Providing opportunities to contribute to research close to home is an important part of person-centred care,” says Kelly Fusco, Manager of Research. “BLUSH demonstrates how research can be embedded directly into routine clinical environments.”
Several key lessons have emerged from the study’s launch:
Collaboration strengthens quality: Engagement with external networks, such as the Canadian Critical Care Trials Group (CCCTG), supports protocol review, shared learning, and methodological rigor.
As the BLUSH study progresses, there is a clear pathway toward multi-centre expansion and continued growth of investigator-led research capacity. This milestone represents more than a single study launch, it signals a sustainable model for community-based research that places patients, clinicians, and evidence generation at the centre of care.