Longitudinal Gene Expression Profiling in Adults After Traumatic Injury

NCT02656459 | Completed

• 1 other identifier: IRB-35447
• Study Type: observational
• Target: 52
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to examine the immune response to traumatic injury and subsequent infections in critically ill adults. Traumatic injuries lead to severe dysregulation of the immune system, and predispose to severe infections. Diagnosing these infections in a timely manner is paramount in reducing morbidity and mortality, but diagnosis is made difficult by the inflammatory response to trauma. The main purpose of the study is to prospectively test the diagnostic power of the expression of an 11-gene set which the investigators recently published (Sweeney et al., Sci Transl Med, 2015). Since the timing of an acquired infection cannot be determined a priori, this study is designed to be a longitudinal examination of a cohort of traumatically injured adults. The investigators will draw blood at regular intervals, as well as at day of diagnosis of infection for any patient that are diagnosed with an infection. The investigators will then assay the blood for gene expression levels post hoc, and correlate the molecular profiles with clinical information to establish a prospective estimate of diagnostic power.

Conditions

Sepsis; Trauma; Infection

Keywords

gene expression

Outcome Measures

Primary Outcomes (1)

• 11-gene set / Sepsis MetaScore

  Time-matched controls are necessary to prevent bias due to changes over time that occur with recovery from injury.

  Patients with infections will be compared to time-matched patients without infections (+/- 24 hours).

Interventions

11-gene set OTHER

This trial is NOT interventional. The 11-gene set / Sepsis MetaScore will be tested post-hoc.

Also known as: Sepsis MetaScore

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

No patients will be enrolled at Stanford. All enrollment will be done at Universitätsmedizin Göttingen. ICU admissions will be reviewed by the local research team; all patients admitted for blunt trauma will then be screened by chart review for matching inclusion/exclusion criteria.

You may qualify if:

• Consecutive adults (\>=18 years old) admitted to the ICU after blunt traumatic injury.

You may not qualify if:

• Patients with isolated traumatic head or spinal cord injuries will not be included.
• Furthermore, patients with prior or under continuous antibiotic therapy will be excluded (e.g. in case of intestinal perforation).
• We will not exclude patients who are given \<=24 hours of perioperative antibiotics.

Sponsors & Collaborators

• Stanford University: lead
• University Medical Center Goettingen: collaborator

Study Sites (3)

Stanford University

Stanford, California, 94305, United States

Location

University Hospital Essen

Essen, 45147, Germany

Location

University of Gottigen

Göttingen, Germany

Location

Related Publications (2)

• Sweeney TE, Shidham A, Wong HR, Khatri P. A comprehensive time-course-based multicohort analysis of sepsis and sterile inflammation reveals a robust diagnostic gene set. Sci Transl Med. 2015 May 13;7(287):287ra71. doi: 10.1126/scitranslmed.aaa5993.

  PMID: 25972003 BACKGROUND

• Sweeney TE, Khatri P. Comprehensive Validation of the FAIM3:PLAC8 Ratio in Time-matched Public Gene Expression Data. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1260-1. doi: 10.1164/rccm.201507-1321LE. No abstract available.

  PMID: 26568247 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood RNA specimens will be retained up to 3 years after study end.

MeSH Terms

Conditions

Sepsis; Wounds and Injuries; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Timothy E Sweeney, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Purvesh Khatri, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 15, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

US (1); DE (2)