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Cytokine Response in Septic Shock

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Dr. Anand Kumar, University of Manitoba.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01770457
First Posted: January 17, 2013
Last Update Posted: July 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Anand Kumar, University of Manitoba
  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 Dr. Anand Kumar, 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 ]

    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 15, 2013
First Posted: January 17, 2013
Last Update Posted: July 25, 2013
Last Verified: July 2013

Keywords provided by Dr. Anand Kumar, University of Manitoba:
ICU population

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