Trailblazing intensive care unit trials
For over three decades, critical care physician Dr Simon Finfer AO has led groundbreaking clinical trials with thousands of participants, shaping global patient care.
His journey began in 2004 with the publication of the first intensive care unit (ICU) mega trial in the world, involving 7,000 patients. This landmark study compared outcomes in patients received fluid resuscitation with either an albumin or saline solution. The study was spurred by an earlier Cochrane review suggesting increased mortality risk associated with albumin use in critically ill patients. “Our study was very influential in not only proving that albumin was safe to use in critically ill patients, but it also changed the landscape of people's thinking about what could be done in terms of proving or disproving the effectiveness and safety of treatments for critically ill patients,” he says. Since then, the Senior Staff Specialist at Royal North Shore Hospital has spearheaded numerous influential trials. In some studies — like in the case of a 6,100-patient ‘NICE-SUGAR study’ which involved controlling blood glucose with large doses of insulin — the results swiftly altered clinical guidelines worldwide. Conducting clinical trials with ICU patients is challenging due to issues around consent and the need to start treatment within minutes or hours. “The patients are usually profoundly unwell, they may be on ventilators, they may be sedated to tolerate such treatments, and you can't seek consent from them,” says Simon. Instead, consent is sought from family members or next of kin, a process which can be stressful for both staff and families and must be handled with care and sensitivity.
But the benefits are wide-reaching. “If we don't include critically ill people in trials, we don't have any other way to improve treatments,” he says, adding that the results will help patients around the world. “It is very gratifying because there is a lot of effort that goes into these trials.” The ‘NICE-SUGAR study’, for example, took eight years of planning, raising funding, setting up the processes, recruiting patients and analysing data. Simon fell into research as a young ICU clinician in the late 1980s and early 1990s, when he could see there was a lack of evidence for some interventions. While he has retired from clinical practice — he’s spent 42 years being on call nights and weekends — he continues to research, focusing on ongoing studies into sepsis. He's never tallied the exact number of trials he has conducted over the years but estimates it to be around 25 to 30, involving nearly 100,000 patients. “The goal has been to try to produce really robust, high-quality evidence to guide clinicians' behaviours in terms of how they treat patients, and therefore to standardise and improve treatment leading to more patients surviving and with a better quality of life.”
18 Tomorrow’s medicine today
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