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.

Phase 2

Conditions: Health Condition 1: A419- Sepsis, unspecified organism

Registration Number: CTRI/2019/03/017928

Lead Sponsor: Venkateswaran R

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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 < 15 ml / min or Bilirubin > 3.6 mg/dL.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures