Colchicine effects in patients with sepsis

Phase 3

Recruiting

• Conditions: Sepsis.; Symptoms and signs specifically associated with systemic inflammation and infection

• Registration Number: IRCT20231017059748N1
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.