Evidence map›Paper›PMID 40544304›Full record

ArticleTrials2025

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

Fariba Pourkarim, Ata Mahmoodpoor, Hassan Soleimanpour, Aliakbar Ghamari, Roghayeh Asghari-Ardabili, Parvin Sarbakhsh, Hadi Hamishehkar

Abstract readClinical Trial Protocol
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Fariba PourkarimDepartment of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
Ata MahmoodpoorDepartment of Anesthesiology and Intensive Care, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
Hassan SoleimanpourDepartment of Anesthesiology and Intensive Care, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
Aliakbar GhamariDepartment of Anesthesiology and Intensive Care, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
Roghayeh Asghari-ArdabiliDepartment of Anesthesiology and Intensive Care, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
Parvin SarbakhshDepartment of Statistics and Epidemiology, Faculty of Public Health, Tabriz University of Medical Sciences, Tabriz, Iran.
Hadi HamishehkarDepartment of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran. hamishehkar@tbzmed.ac.ir.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 .

Indexed as

Anti-Inflammatory AgentsColchicineSepsisAdolescentAdultAgedAged, 80 and overBiomarkersDouble-Blind MethodFemaleHumansInterleukin-6IranMaleMiddle AgedOrgan Dysfunction ScoresAnti-Inflammatory AgentsBiomarkersColchicineIL6 protein, humanInterleukin-6Anti-inflammatoryClinical trialColchicineCOLINSIL-6Sepsis

Identifiers

PMID40544304
PMCPMC12182685

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.