NCT01503684

Brief Summary

In this proposal, the investigators wish to investigate, identify and validate potential biomarkers in collected exhaled breath condensates (EBC) from patients with sepsis.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
Last Updated

January 4, 2012

Status Verified

September 1, 2011

First QC Date

January 2, 2012

Last Update Submit

January 3, 2012

Conditions

Sepsis

Keywords

sepsis

Outcome Measures

Primary Outcomes (1)

  • Development and severity of sepsis

    To record APACHE II, SOFA, and MODS, etc.

    28 days

Secondary Outcomes (2)

  • Mortality

    28 days

  • Response to treatment and progression of organ failure

    28 days

Study Arms (1)

Patients with sepsis

Patients who are admitted to ICU with the diagnosis of sepsis

Other: Determined by intended physician

Interventions

Determined by intended physicianOTHER

We perform a prospective observational study. All the treatment for the patients are determined by intended physicians.

Patients with sepsis

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are admitted to ICU with the diagnosis of sepsis and treated with mechanical ventilation via an endotracheal tube.

You may qualify if:

  • above 20 years old
  • admitted to ICU with the diagnosis of sepsis and treated with mechanical ventilation via an endotracheal tube

You may not qualify if:

  • pregnant
  • active malignancy
  • in an immunosuppressed status such as HIV disease, neutropenia, being treated with immunosuppressive agents
  • expected to have an unavoidable very short life expectancy after admission, i.e., \< 3 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled breath condensate

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jih-Shuin Jerng, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jih-Shuin Jerng, MD,PhD

CONTACT

886-2-23562905jsjerng@ntu.edu.tw

Study Design

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

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 4, 2012

Study Start

August 1, 2011

Last Updated

January 4, 2012

Record last verified: 2011-09

Locations

TW(1)