Indicators of Inflammation and Coagulation in Sepsis | NCT01128283

Studies
Indicators of Inflammation and Coagulation in Sepsis

NCT01128283

Sponsor

University of Oklahoma

Status

Completed

Last Update Posted

Sep 12, 2014Estimated

Enrollment

500Actual

Phase

Not provided

Conditions

Sepsis

Interventions

Not provided

Countries

United States

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

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

May 20, 2010

First Submission Date that Met QC Criteria

May 20, 2010

First Posted Date

May 21, 2010Estimated

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

Sep 11, 2014

Last Update Posted Date

Sep 12, 2014Estimated

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

We will collect blood samples from patients with the diagnosis of sepsis and other ICU patients. We will describe the course of different mediator levels and organ injury markers and follow their progression throughout the course of the study.

Detailed Description

After informed consent is obtained 5 cc of blood is collected on the day of admission and on days 0, 1, 3, and 7 thereafter. Plasma is collected and frozen for the subsequent measurement of biomarkers.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sepsis		Patients with severe sepsis
Non-infected		ICU patients without evidence of infection

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Death	Survival at 30 days	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admission to the ICU

Exclusion Criteria:

No blood draws scheduled
Hemoglobin level < 6,5 gm/dl

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

ICU patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gary T. Kinasewitz, MD	University of Oklahoma	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OU Medical Center		Oklahoma City	Oklahoma	73104	United States

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

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