Cytokine Response in Septic Shock

Septic Shock Clinical Trial

Official title:

Cytokine Response in Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01770457
• Other study ID #: B2009:130
• Status: Recruiting
• Phase: N/A
• First received: January 15, 2013
• Last updated: July 24, 2013
• Start date: April 2006
• Est. completion date: December 2014

Study information

• Verified date: July 2013
• Source: University of Manitoba
• Contact: Anand Kumar, MD
• Phone: 204-291-0372
• Email: akumar61[@]yahoo.com
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 325
• Est. completion date: December 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
Canada	Health Sciences Centre, Winnipeg	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine response in septic shock	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).	Hours 0, 3, 6, 12, 18, 24, 36, 48, 96 and day 7	No