Colchicine effects in patients with sepsis

Evaluation of colchicine effects in patients with sepsis: A double-blind, randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231017059748N1

Enrollment

Registered

2023-10-21

Start date

2024-10-11

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis. Symptoms and signs specifically associated with systemic inflammation and infection

Interventions

Intervention 1: Intervention group: Patients will receive 1 mg colchicine daily for 10 days in addition to usual treatments. Intervention 2: Control group: Patients will receive a placebo daily for 10

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1- Sepsis patients 2 - Aged 18 to 80 years 3 - High CRP3 at baseline 4 - Consented patients

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1- Hypersensitivity to colchicine or other components of the formulation, 2- Hepatic failure (Child-Puff score B and C), 3- Renal failure (eGFR <15 mL/min/1.73 m2), 4- Malignancy, 5- Pregnancy, 6- Breastfeeding 7- Concomitant use of fusidic acid- lasmiditan- nirmatrelvir- pacritinib- fexinidazole.

Design outcomes

Primary

Measure	Time frame
Interleukin-6 plasma level. Timepoint: before the start and day 4 of the study. Method of measurement: ELISA kit.	—

Secondary

Measure	Time frame
Erythrocyte sedimentation rate. Timepoint: Days 1, 4, 10. Method of measurement: Blood sample.;C-reactive protein. Timepoint: Days 1, 4, 10. Method of measurement: Blood sample.;Procalcitonin plasma level. Timepoint: Days 1, 4. Method of measurement: Blood sample.;Liver function tests. Timepoint: Days 1, 4, 10. Method of measurement: Measurement of liver enzymes.;Cell blood count. Timepoint: Days 1, 4, 10. Method of measurement: Blood sample.;Serum creatinine. Timepoint: Days 1, 4, 10. Method of measurement: Blood sample.;Lactate dehydrogenase plasma level. Timepoint: Days 1, 4, 10. Method of measurement: Blood sample.;Duration of need for supplemental oxygen, duration of need for mechanical ventilation and duration of need for vasopressor. Timepoint: Days 1 to 10. Method of measurement: questionnaire.;The state of organ failure in sepsis. Timepoint: Days 1, 4, 10. Method of measurement: Sequential Organ Failure Assessment (SOFA) Score.	—

Measure

Time frame

Erythrocyte sedimentation rate. Timepoint: Days 1, 4, 10. Method of measurement: Blood sample.;C-reactive protein. Timepoint: Days 1, 4, 10. Method of measurement: Blood sample.;Procalcitonin plasma level. Timepoint: Days 1, 4. Method of measurement: Blood sample.;Liver function tests. Timepoint: Days 1, 4, 10. Method of measurement: Measurement of liver enzymes.;Cell blood count. Timepoint: Days 1, 4, 10. Method of measurement: Blood sample.;Serum creatinine. Timepoint: Days 1, 4, 10. Method of measurement: Blood sample.;Lactate dehydrogenase plasma level. Timepoint: Days 1, 4, 10. Method of measurement: Blood sample.;Duration of need for supplemental oxygen, duration of need for mechanical ventilation and duration of need for vasopressor. Timepoint: Days 1 to 10. Method of measurement: questionnaire.;The state of organ failure in sepsis. Timepoint: Days 1, 4, 10. Method of measurement: Sequential Organ Failure Assessment (SOFA) Score.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Hamishehkar

Tabriz University of Medical Sciences

hamishehkar@gmail.com+98 41 3334 7054

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026