Genetic Polymorphisms & The Risk for Sepsis After Trauma

Completed

• Conditions: Trauma
• Interventions: Other: blood sampling

• Registration Number: NCT02021552
• Lead Sponsor: University of Washington

Brief Summary

The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death.

Detailed Description

The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-27
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 357

Inclusion Criteria

Admitted to the Intensive Care Unit (ICU) at Harborview Medical Center after suffering a traumatic injury

• ability to obtain a 5 ml blood sample
• Expected to be in the ICU for more than 24 hours

Exclusion Criteria

• We will exclude subjects with chronic medical conditions for the reasons stated above as well as vulnerable populations (children, pregnant females, and prisoners)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
trauma patients	blood sampling	trauma patients 18 years or older requiring treatment in the ICU \>24 hours. All subjects will undergo blood sampling.

Primary Outcome Measures

Name	Time	Method
Investigators aim to identify up to 100 single-nucleotide polymorphisms (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death.	3 years	The investigators will be studying whether baseline genetic difference can be used in the future to identify patients at high risk and conversely those at low risk for complicated post-traumatic infections.

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States