Cytokine Response in Septic Shock

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
Dr. Anand Kumar, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01770457
First received: January 15, 2013
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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).


Condition
Septic Shock

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Cytokine Response in Septic Shock

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Cytokine response in septic shock [ Time Frame: Hours 0, 3, 6, 12, 18, 24, 36, 48, 96 and day 7 ] [ Designated as safety issue: No ]

    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).



Biospecimen Retention:   Samples Without DNA

Serum samples will be collected at specific time points. Initial time point determined by start of Vasopressors Then sequential serum samples will be drawn from patients to examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc)


Estimated Enrollment: 325
Study Start Date: April 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All adult patients with septic shock admitted to intensive care units who are receiving vasopressors for septic shock for <24 hrs. No significant exclusions exist.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770457

Contacts
Contact: Anand Kumar, MD 204-291-0372 akumar61@yahoo.com
Contact: Wendy Janz, RN 204-787-1405 wjanz@hsc.mb.ca

Locations
Canada, Manitoba
Health Sciences Centre, Winnipeg Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Wendy Janz, RN    204-787-1405    wjanz@hsc.mb.ca   
Principal Investigator: Anand Kumar, MD         
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Anand Kumar, MD University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Anand Kumar, Attending physician/ investigator WRHA, University of Manitoba
ClinicalTrials.gov Identifier: NCT01770457     History of Changes
Other Study ID Numbers: B2009:130
Study First Received: January 15, 2013
Last Updated: July 24, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
ICU population

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on September 18, 2014