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Sunnybrook researchers awarded more than $6M in CIHR clinical trials funding

January 23, 2023

Sunnybrook researchers have been awarded nearly $6.8M in funding from the Canadian Institutes of Health Research (CIHR) Spring 2022 Clinical Trials Fund.

The Clinical Trials Fund is designed to enhance Canada’s clinical trials ecosystem from discovery to implementation, determining which new drugs, treatments, and therapies are safe and effective for the population. In total, CIHR’s latest round of funding includes one clinical trials consortium, seven training platforms, and 22 research projects for a total investment of more than $130M.

Congratulations to the three Sunnybrook-led projects.

Project: BALANCE+: A Platform Trial for Gram Negative Bloodstream Infections
Principal Investigator: Dr. Nick Daneman
Sunnybrook co-principal Investigator: Dr. Rob Fowler
Funding: $2,919,785

Project overview: »

Bloodstream infections are a leading cause of death in Canada and worldwide, yet remain understudied, such that the best treatment strategies to cure the infection while minimizing harms of excess antibiotics causing antimicrobial resistance are still unknown.

The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) randomized controlled trial is currently comparing 7 versus 14 days of antibiotic treatment for bloodstream infection and has recruited nearly 3400 patients across 73 hospitals. BALANCE is the largest trial ever conducted among patients with bloodstream infection, and when it concludes this year will answer a fundamental treatment duration question. However, many crucial questions will remain.

The new BALANCE+ trial will answer further questions that are important for patients with the most common kind of bloodstream infections. All hospitalized adult patients with the most common kind of bloodstream infections – caused by 'Gram negative' bacteria – will be eligible to participate. This trial provides a platform upon which to answer multiple questions looking at: the best ways to step-down antibiotic treatment, the best management approach when an infection is caused by bacteria on a catheter, and some key antibiotic selection questions for difficult to treat pathogens. As each question is answered, optimal therapies will be adopted into usual care, and new questions will be introduced into the platform of the trial. The evidence generated by BALANCE+ will improve cure for this vulnerable patient population while decreasing potential harms from using too many antibiotics for too long.

Project: Advancing Brain Outcomes in pediatric critically ill patients sedated with Volatile AnEsthestic Agents: A pilot multicentre randomized controlled trial (ABOVE Trial)
Principal investigator: Dr. Angela Jerath
Sunnybrook co-principal investigator: Dr. Brian Cuthbertson
Funding: $1,121,996

Project overview: »

In children needing life-saving critical care, over 50% suffer from an acute brain disorder called delirium which presents as poor concentration, memory and attention. Unfortunately, delirium has no treatment and leads to higher risk of childhood death, longer hospital stays and higher costs of care. For families, their child is irritable, may not recognize them when they visit, and can lead to longer-term care burdens as delirium has been linked to slower and impaired childhood brain and behaviour development after hospital discharge. Many sick children need support from a ventilator, which requires intravenous (IV) sedatives to tolerate this uncomfortable procedure. Unfortunately, current sedatives may contribute to delirium through a combination of pharmacological and patient factors.

Inhaled sedatives are an alternative to currently used IV sedatives, and they may reduce delirium and accelerate brain recovery. Inhaled sedatives are used safely every day in operating rooms, widely available and inexpensive. In contrast to IV sedatives, they do not accumulate in the body, are rapidly eliminated via the lungs, promote faster awakening and liberation from the ventilator, and reduce inflammation, which may reduce delirium.

The ABOVE trial aims to evaluate the feasibility of using sedation with inhaled anesthetics in critically ill children, assess its safety and provide early information on delirium compared to IV sedatives. The research team will follow children who survive their hospital stay for one year to study any differences in intellectual and behaviour development. The information gathered will be used to conduct a larger study to see if inhaled anesthetics provide better sedation in critically ill children and reduce delirium. This study is unique for North America and will introduce a new type of sedation care for sick children worldwide.

Project: The Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation (CLEAN Wound) Trial
Principal Investigator: Dr. Paul Karanicolas
Sunnybrook co-principal investigator: Dr. Stephanie Mason
Funding: $2,750,148

Project overview: »

A surgical site infection (SSI) is an infection that occurs after a surgical procedure. Despite a variety of infection prevention strategies, SSIs still occur often and impose a significant burden on patients and the healthcare system. Intraoperative irrigation (or washing of the surgical incision before closure) may reduce SSIs, but this is uncertain.

The Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation (CLEAN Wound) trial aims to determine if incisional wound irrigation with an antiseptic or salt water solution can reduce SSIs within 30 days of surgery compared to no wound irrigation. 2,500 patients aged 18 years or older who are scheduled to undergo an abdominal or groin open or laparoscopic elective procedure will be randomly assigned to incisional wound irrigation with povidone-iodine solution; or incisional wound irrigation with saline; or no irrigation and followed for 30 days after surgery to assess the incidence of SSIs, with additional outcomes collected up to 90 days after surgery.

Even with significant advances in medicine over the past decades, there are still many fundamental issues in perioperative care that remain unclear due to lack of evidence. If this trial were to demonstrate that intraoperative wound irrigation reduces the incidence of SSI, these practice-changing findings could greatly benefit patients worldwide.