NCT01012115

Brief Summary

In an effort to better understand the interaction between the different mediators, the investigators propose to examine the time course of mediators, the indexes of organ injury and the coagulation cascade.

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 Oct 2009

Geographic Reach
1 country

2 active sites

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

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

April 9, 2012

Status Verified

April 1, 2012

Enrollment Period

1.9 years

First QC Date

November 9, 2009

Last Update Submit

April 5, 2012

Conditions

Sepsis

Keywords

Histonesorgan failuresepsis

Eligibility Criteria

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

Patients admitted to the ICU with suspected or proven sepsis.

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 (2)

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs 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

    OU Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 9, 2009

First Posted

November 11, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

April 9, 2012

Record last verified: 2012-04

Locations

US(2)