A clinical trial to study the effect of the drug called Colchicine in patients with abnormally low blood pressure due to infection that has spread all over the body.

Effect of Colchicine in Septic Shock (COLISEPS Trial) â?? A Pilot Study. - COLISEPS Trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/03/017928

Enrollment

300

Registered

2019-03-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: A419- Sepsis, unspecified organism

Interventions

Intervention1: Colchicine: Tablet Colchicine containing 0.5 milligram as an immediate release preparation, dissolved in 10 ml of water, administered orally via the Naso-gastric tube, three times a day

Eligibility

Inclusion criteria

Inclusion criteria: Patients with sepsis who have a vasopressor requirement to maintain a MAP of 65 mmHg or more and a serum lactate of more than 2 mmol/L (18 mg/dL) in the absence of hypovolemia.

Exclusion criteria

Exclusion criteria: 1. Refractory septic shock. 2. Circulatory shock attributed to primary cardiac disease or pulmonary embolism. 3. Late septic shock defined as patients beyond 24 hours of onset of septic shock. 4. Sepsis like syndromes: Poly-Trauma, Acute pancreatitis and Burns. 5. Anticipated rapid fatality from irreversible underlying disease or terminal malignancy. 6. APACHE II score > 36. 7. Readmission into Medical ICU within 90 days of previous admission 8. Post Cardiopulmonary Resuscitation status of the patient in the current admission. 9. Concurrent use of drugs known to interact with Colchicine: Clarithromycin, Erythromycin, Telithromycin, Statins, Cyclosporine, Verapamil and Diltiazem. 10. Pregnancy and Lactation. 11. Renal dysfunction with GFR 3.6 mg/dL.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and efficacy of Colchicine at a dose of 1.5 mg per day, in comparison to Placebo, on the 28-day all-cause mortality in patients with septic shock.Timepoint: FROM Day of Enrollment TO Day-28 of Onset of Septic Shock.	—

Secondary

Measure	Time frame
To assess the effect of Colchicine on the duration of hospital stay in patients with septic shock.Timepoint: From Day of Enrollment to Day of Transferring out of Intensive Care Unit.;To assess the effect of Colchicine on the infectious complications in patients with septic shock.Timepoint: From Day of Enrollment to Day of Transferring out of Intensive Care Unit.;To assess the effect of Colchicine on the number of ventilator dependent days in patients with septic shock.Timepoint: From Day of Enrollment to Day of Transferring out of Intensive Care Unit.;To assess the effect of Colchicine on the serum levels of inflammatory bio-markers in patients with septic shock.Timepoint: At baseline, 48 hours and 96 hours after enrollment.;To assess the effect of Colchicine on the use of antibiotics in patients with septic shock.Timepoint: From Day of Enrollment to Day of Transferring out of Intensive Care Unit.;To study the difference in survival (time-to-event) and 90-day all-cause mortality between the two group of patients.Timepoint: From Day of Enrollment to Day-90 of Onset of Septic Shock.	—

Measure

Time frame

To assess the effect of Colchicine on the duration of hospital stay in patients with septic shock.Timepoint: From Day of Enrollment to Day of Transferring out of Intensive Care Unit.;To assess the effect of Colchicine on the infectious complications in patients with septic shock.Timepoint: From Day of Enrollment to Day of Transferring out of Intensive Care Unit.;To assess the effect of Colchicine on the number of ventilator dependent days in patients with septic shock.Timepoint: From Day of Enrollment to Day of Transferring out of Intensive Care Unit.;To assess the effect of Colchicine on the serum levels of inflammatory bio-markers in patients with septic shock.Timepoint: At baseline, 48 hours and 96 hours after enrollment.;To assess the effect of Colchicine on the use of antibiotics in patients with septic shock.Timepoint: From Day of Enrollment to Day of Transferring out of Intensive Care Unit.;To study the difference in survival (time-to-event) and 90-day all-cause mortality between the two group of patients.Timepoint: From Day of Enrollment to Day-90 of Onset of Septic Shock.

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Countries

India

Contacts

Public ContactVenkateswaran R

JIPMER, Puducherry

drvenks@gmail.com9488505555

Outcome results

None listed

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