Grant: Project Grant

Septic shock is a common condition arising from severe infection, and an important cause of morbidity and mortality worldwide. Septic shock can result in very low blood pressure, which compromises blood flow to major organs, potentially leading to organ failure and death. Fluid resuscitation, antimicrobial therapy, and vasopressors are standard treatment for septic shock. Despite this, mortality rates remain as high as 40%. In Canada, sepsis and septic shock is the 3rd most common cause of death (www.statscan.gov.ca). Therefore, there is an urgent need for alternative therapeutic agents in the care of patients with septic shock. Methylene blue (MB) is a medication that has been used to raise blood pressure in patients with acute drug poisoning, anaphylaxis, and other conditions. Despite the evidence of MB's benefits, very little data on its effects in septic shock exist. The objective of this project is to determine the feasibility of conducting a larger trial comparing MB with usual care in septic shock. We will evaluate important feasibility metrics such as recruitment, consent, and compliance, in order to ensure a definitive trial is possible. Critically ill patients with septic shock will be enrolled. Patients in the treatment arm will be treated with MB, and patients with the control arm will receive usual care for septic shock (without MB). Patients will be monitored for outcomes such as duration of vasopressors, need for dialysis, and death until discharge or 28 days. The BLUSH trial has the potential to change the management of patients with septic shock in ICUs, operating rooms, and emergency departments across Canada. Although MB is relatively cheap and widely available, clinical practice is unlikely to change without further robust evidence addressing this question. The results of this RCT will also inform international clinical practice guidelines that currently make no recommendation regarding the use of MB in septic shock.