Transcriptomic Profiling in Severely Injured Patients

Sepsis Clinical Trial

Official title:

Transcriptomic Profiling in Severely Injured Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508272
• Other study ID #: Stv26/2007
• Status: Completed
• Phase: N/A
• First received: July 20, 2015
• Last updated: July 22, 2015
• Start date: December 2009
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

Discovery of differences in the host response in patients with systemic inflammation and sepsis, and identification of novel, specific markers by using a longitudinal clinico-transcriptomic approach.

Description:

The aim of this study is to link defined clinical phenotypes with data on RNA obtained from blood samples by high throughput technologies. Genetic and molecular characteristics of the immune system after severe trauma will be crosslinked to clinical aspects of posttraumatic organ failure, with the goal of identifying typical molecular "fingerprints". Patients with and without sepsis or organ failure will be compared with the goal to develop a diagnostic test designed to predict the clinical course following severe trauma. Criteria for study enrollment includes patient age ≥18 y, an Injury Severity Score (ISS) ≥ 17 points, and time from injury to admission < 6 h. Whole blood from trauma patients will be collected within the first 6 h after trauma (day 0) and on days 1, 2, 3, 5, 7, 10, 14, and 21.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 2015
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient age =18 y

• Injury Severity Score (ISS) = 17 points

• time from injury to admission < 6 h.

Exclusion Criteria:

Moribund Patients with:

• PH < 7,1 or

• Lactate > 15 mmol/l or

• Base deficit > 15 mEq/l

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammation
• Sepsis
• Trauma

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Trauma Surgery	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic Inflammation and Sepsis		21 days after trauma	No
Secondary	Mortality		28 days after Trauma	No
Secondary	Nosocomial infections		21 days after trauma	No
Secondary	SOFA score		21 days after trauma	No
Secondary	Systemic inflammation score		21 days after trauma	No
Secondary	Hospital length of stay		28 days after trauma	No
Secondary	ICU length of stay		28 days after trauma	No