Acupuncture to Improve Outcomes in Patients with Sepsis: a Randomized Controlled Trial - PROJECT SUMMARY/ABSTRACT: Sepsis is a life-threatening medical condition characterized by high levels of inflammatory markers and multi-organ damage. Despite standard treatment, sepsis remains a leading cause of morbidity and mortality in critically ill patients, especially cancer patients. Recently, it has been shown that acupuncture can induce dopamine production, suppress inflammation, and reduce sepsis in animal studies. Several randomized controlled clinical trials have shown that acupuncture may reduce mortality in sepsis patients. However the trials were unblinded and at risk for bias. Here we propose to fill the knowledge gap by conducting a randomized controlled, patient and evaluator blinded, phase 2 trial of acupuncture (the ACTIONS trial), using sham acupuncture as control, in patients at risk for sepsis. The specific Aims are: 1) to generate preliminary data for the estimated effect size of acupuncture in reducing mortality and ICU (Intensive Care Unit) admission of sepsis patients and to determine the feasibility of conducting a randomized controlled trial of acupuncture in hospitalized patients who are at risk for sepsis; and 2) to explore whether acupuncture increases catecholamines and reduces inflammatory cytokines more than sham acupuncture. Seventy-eight patients at risk for sepsis, will be randomized to true or sham acupuncture daily for 10 days or until transfer to ICU, death, or discharge. Feasibility endpoints include as accrual rate, intervention delivery rate, attrition rate, and data completion rate. Efficacy endpoints include mortality and rate of ICU admission. Biomarker endpoints are plasma levels of catecholamines and pro-inflammatory cytokines, measured before and after the first acupuncture treatment. If this study shows that acupuncture is deemed feasible and the estimated effect size warrant a larger study, we plan to conduct a randomized controlled phase 3 study evaluate the definitive efficacy of acupuncture in improving outcomes of sepsis patients. The proposed study would be the first one acupuncture study on sepsis using sham acupuncture as control. The data will also shed light on the mechanism of action of acupuncture. This project has the potential of developing acupuncture as an innovative clinical approach in the management of sepsis. It challenges the current clinical practice paradigm and can lead to reduction of deaths due to sepsis.
