NCT02508272

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

July 20, 2015

Last Update Submit

July 22, 2015

Conditions

TraumaInflammationSepsis

Keywords

Transcriptome profiling

Outcome Measures

Primary Outcomes (1)

  • Systemic Inflammation and Sepsis

    21 days after trauma

Secondary Outcomes (6)

  • Mortality

    28 days after Trauma

  • Nosocomial infections

    21 days after trauma

  • SOFA score

    21 days after trauma

  • Systemic inflammation score

    21 days after trauma

  • Hospital length of stay

    28 days after trauma

  • +1 more secondary outcomes

Study Arms (1)

Trauma patients

age ≥18 y ISS ≥ 17 points admission \< 6 h.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Trauma patients with systemic inflammation due to multiple injuries (Polytrauma: ISS ≥ 17 points)

You may qualify if:

  • patient age ≥18 y
  • Injury Severity Score (ISS) ≥ 17 points
  • time from injury to admission \< 6 h.

You may not qualify if:

  • Moribund Patients with:
  • PH \< 7,1 or
  • Lactate \> 15 mmol/l or
  • Base deficit \> 15 mEq/l

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Trauma Surgery

Zurich, CH-8091, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

total RNA. Serum, Plasma

MeSH Terms

Conditions

Wounds and InjuriesInflammationSepsis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response Syndrome

Study Officials

  • Guido A Wanner, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 20, 2015

First Posted

July 24, 2015

Study Start

December 1, 2009

Primary Completion

March 1, 2012

Study Completion

July 1, 2015

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations

CH(1)