CompletedNot Applicable

Clinical Study Evaluating the Efficacy and Safety of Colchicine in Adult Patients With Sepsis

Egypt46 participantsStarted 2023-11-01

Plain-language summary

Inflammatory markers are found to be an important contributor in sepsis. We evaluate the effect of colchicine on inflammatory processes and its possible protective effect against oxidative stress and organ dysfunction in adult patients suffering from sepsis.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* Inclusion criteria: * Adult age ≥18 years old. * Both male and female sex. * Patients diagnosed with sepsis regardless its etiology according to the definitions of SSC . * Exclusion criteria: * Late septic shock at presentation with multiple organ failure. * Serious gastrointestinal disease. * Preexisting end stage liver disease. * Preexisting end stage renal disease * Pregnancy and breast-feeding women. * History of allergy or intolerance to Colchicine. * Patient with malignancies. * Uncontrolled hemorrhage. * Burn. * Patients on immunosuppressant or biological therapies. * Concomitant use of P-glycoprotein (P-gp) inhibitor such as: Verapamil, and Amiodarone or strong CYP3A4 inhibitor such as: Clarithromycin, Ritonavir and Ketoconazole.

What they're measuring

change in the measured biological marker Serum Tumor necrosis factor-alpha (TNF-α) .

Timeframe: 10 Months

change in the measured biological marker Serum Malondialdehyde (MDA).

Timeframe: 10 Months

Trial details

NCT IDNCT07074990

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-30

View on ClinicalTrials.gov More Sepsis at Intensive Care Unit trials