Indicators of Inflammation and Coagulation in Sepsis

Sepsis Clinical Trial

Official title:

Temporal Behavior of Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128283
• Other study ID #: 09681
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: September 11, 2014
• Start date: January 2002
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission to the ICU

Exclusion Criteria:

• No blood draws scheduled

• Hemoglobin level < 6,5 gm/dl

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
United States	OU Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Survival at 30 days	30 days	No