NCT01128283

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

12.3 years

First QC Date

May 20, 2010

Last Update Submit

September 11, 2014

Conditions

Sepsis

Keywords

Sepsisorgan failurecytokinesclotting factors

Outcome Measures

Primary Outcomes (1)

  • Death

    Survival at 30 days

    30 days

Study Arms (2)

Sepsis

Patients with severe sepsis

Non-infected

ICU patients without evidence of infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients

You may qualify if:

  • Admission to the ICU

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gary T. Kinasewitz, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2010

First Posted

May 21, 2010

Study Start

January 1, 2002

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

US(1)