Cytokine Response in Septic Shock | NCT01770457

Studies
Cytokine Response in Septic Shock

NCT01770457

Sponsor

University of Manitoba

Status

Unknown status

Last Update Posted

Jul 25, 2013Estimated

Enrollment

325Estimated

Phase

Not provided

Conditions

Septic Shock

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Feb 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Jan 15, 2013

First Submission Date that Met QC Criteria

Jan 15, 2013

First Posted Date

Jan 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2013

Last Update Posted Date

Jul 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Anand Kumar, Attending physician/ investigator WRHA, University of ManitobaPrincipal Investigator

Lead Sponsor

University of ManitobaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

325Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anand Kumar, MD	Contact	204-291-0372		akumar61@yahoo.com
Wendy Janz, RN	Contact	204-787-1405		wjanz@hsc.mb.ca

Overall Officials

Name	Affiliation	Role
Anand Kumar, MD	University of Manitoba	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Sciences Centre, Winnipeg	Recruiting	Winnipeg	Manitoba	R3A 1R9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic

Ancestor Terms

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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)