The effect of Colchicine IN Sepsis (COLINS): a study protocol for a randomized, double-blind, placebo-controlled...

Sepsis is a life-threatening condition with high mortality rates of up to 40% due to multiple organ dysfunction. Systemic inflammatory response plays a key role in the pathophysiology and progression of this disease. Therefore, anti-inflammatory drugs can be considered as augmentation therapy for the management of the early phase of inflammation in septic patients, along with appropriate antimicrobial therapy and source control. Experimental studies suggest the beneficial effects of colchicine in animal septic models. However, the clinical effects of colchicine in the setting of sepsis have not been investigated yet.

This prospective, double-blinded, placebo-controlled, randomized trial will be conducted at Imam Reza Hospital, the largest northwest referral hospital, in Tabriz, Iran. A total of 44 patients aged 18 to 80 years with sepsis diagnosis will be randomized 1:1 to receive colchicine 1 mg daily or placebo for 10 days. The primary outcome is interleukin-6 (IL-6) changes from the baseline through day 4. Sequential organ failure assessment (SOFA) and qSOFA scores will be evaluated at baseline, day 4, and day 10. Patients will be assessed regarding the need for supplemental oxygen, mechanical ventilation, and vasopressor from the randomization through day 4 and day 10.

The Colchicine IN Sepsis (COLINS) trial will be the first to investigate colchicine's efficacy versus placebo in sepsis patients. The results of this trial will be a step forward in treating patients with sepsis.

Clinical trial ID: IRCTID: IRCT20231017059748N1. Registration date: 21 October 2023. https://irct.behdasht.gov.ir/trial/73232 .