$5M grant awarded to investigate combination therapy in septic shock
A first-of-its-kind study looking at increasing survival and recovery rates for sepsis patients has been awarded a $4.99 million grant through the Clinical Trials Activity program in the Medical Research Future Fund. The FludrocortIsoNE in Septic Shock Evaluation: FINESSE adaptive randomised clinical trial will be conducted by The George Institute for Global Health in conjunction with Sepsis Australia.
Led by Associate Professor Naomi Hammond, Program Head of Critical Care at The George Institute for Global Health and UNSW Sydney, and Executive Director, Research at Northern Sydney Local Health District, FINESSE will explore different doses of a corticosteroid – fludrocortisone - in combination with hydrocortisone on survival and functional outcomes for critically ill patients with septic shock, versus hydrocortisone alone.
Sepsis is a major global public health problem impacting an estimated 50 million people and causing 11 million deaths (one in five of all deaths) every year, including around 8,700 in Australia, surpassing deaths from colorectal cancer, breast cancer and road accidents.
Sepsis research is characterised by many failed trials, with 90-day mortality rates in septic shock remaining unacceptably high - above 30% - for the past 10 years. This indicates a high unmet need for improved adjunct therapies including corticosteroids. These medicines have shown promise, but trials have not been conclusive.
By:Associate Professor Naomi Hammond
Program Head, Critical Care, The George Institute for Global Health and UNSW Sydney
Some studies suggest combining hydrocortisone with fludrocortisone can reduce the risk of death. However, without substantial evidence, many doctors are unsure about its use and proper dosage.
Our study has the potential to reduce death and long-term disability in people with sepsis. By answering the lingering question of whether fludrocortisone in combination with hydrocortisone is effective, we could make a huge impact globally on patient survival, get more people well and back to living their lives sooner, and also reduce the burden on costly intensive care services in hospitals.
By:Associate Professor Naomi Hammond
Program Head, Critical Care, The George Institute for Global Health and UNSW Sydney
Fludrocortisone and hydrocortisone are both low-cost, widely available medicines. Improving recovery time by just one day for 55,000 patients in Australia would save $122 million a year in healthcare costs. FINESSE will deliver an economic evaluation and follow patients for 12 months to assess their quality of life.
The FINESSE program builds on previously funded NHMRC trials led by Professor Balasubramanian Venkatesh, Program Director of Critical Care at The George Institute for Global Health and UNSW Sydney, and over a decade of consultation and partnership with consumers with lived experience, health consumer groups, professional societies, academics, government, and funding agencies.
The role of steroids in septic shock has remained controversial for more than 70 years. The FINESSE trial is uniquely placed to answer that question.
By:Professor Balasubramanian Venkatesh
Program Director, Critical Care, The George Institute for Global Health and UNSW Sydney
Related links
Adjunctive Glucocorticoid Therapy in Patients with Septic Shock | New England Journal of Medicine
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