NCT01770457

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 25, 2013

Status Verified

July 1, 2013

Enrollment Period

7.8 years

First QC Date

January 15, 2013

Last Update Submit

July 24, 2013

Conditions

Keywords

ICU population

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Centre, Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

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)

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Anand Kumar, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anand Kumar, MD

CONTACT

Wendy Janz, RN

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician/ investigator WRHA

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

April 1, 2006

Primary Completion

February 1, 2014

Study Completion

December 1, 2014

Last Updated

July 25, 2013

Record last verified: 2013-07

Locations