Cytokine Response in Septic Shock

• Conditions: Septic Shock

• Registration Number: NCT01770457
• Lead Sponsor: University of Manitoba

Brief Summary

This study is designed to examine the early sequential cytokine responses during antibiotic therapy and resuscitation of septic shock in relation to clinical manifestations of disease.

The specific objective is to obtain sequential serum samples from patients with septic shock, examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc) in a rigorous manner and correlate these responses to administration of antibiotics, resuscitative efforts and physiologic responses to illness (temp, HR, blood pressure, WBC, etc).

Detailed Description

Patients must be on vasopressors Patients cannot be on pressors for \> 24 hrs prior to consent

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-24
• Last Update Posted: 2013-07-25
• Primary Completion: 2014-02
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

• Adult ICU patients: . 18 years admitted with septic shock
• Receiving Vasopressors < 24 hrs

Exclusion Criteria

• Consent refused by patient or SDM
• Received Vasopressors > 24hrs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cytokine response in septic shock	Hours 0, 3, 6, 12, 18, 24, 36, 48, 96 and day 7	his study is designed to examine the early sequential cytokine responses during antibiotic therapy and resuscitation of septic shock in relation to clinical manifestations of disease.; The specific objective is to obtain sequential serum samples from patients with septic shock, examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc) in a rigorous manner and correlate these responses to administration of antibiotics, resuscitative efforts and physiologic responses to illness (temp, HR, blood pressure, WBC, etc).

Trial Locations

Locations (1)

Health Sciences Centre, Winnipeg; 🇨🇦 Winnipeg, Manitoba, Canada