ArticleTrials2025
The effect of Colchicine IN Sepsis (COLINS): a study protocol for a randomized, double-blind, placebo-controlled trial.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
7 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundSepsis 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.
methodsThis 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. DISCUSSION: 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.
trial registrationClinical trial ID: IRCTID: IRCT20231017059748N1. Registration date: 21 October 2023. https://irct.behdasht.gov.ir/trial/73232 .
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