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CompletedNCT01128283Updated Sep 12, 2014

Indicators of Inflammation and Coagulation in Sepsis

An observational study in Sepsis, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-12.

Sponsored by University of Oklahoma · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sepsis

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Keywords

  • Sepsis
  • organ failure
  • cytokines
  • clotting factors
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 500 is above the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ICU patients

Inclusion criteria

  • Admission to the ICU

Exclusion criteria

Exclusion Criteria:

  • No blood draws scheduled
  • Hemoglobin level \< 6,5 gm/dl
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
500 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Sepsis

    Patients with severe sepsis

  • Non-infected

    ICU patients without evidence of infection

06

What researchers measure

Primary outcomes

  1. Death

    Survival at 30 days

    Time frame: 30 days

07

Study locations

1 site
  • OU Medical Center
    Oklahoma City, Oklahoma 73104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01128283
Lead sponsor
University of Oklahoma
Responsible party
Gary Kinasewitz (Principal Investigator, University of Oklahoma) — Principal investigator
First posted
May 21, 2010
Start date
Jan 2002
Primary completion
May 2014
Completion
May 2014
Last update
Sep 12, 2014

Study contacts

Gary T. Kinasewitz, MD
principal investigator · University of Oklahoma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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