NCT01388725

Brief Summary

The purpose of this study is to describe the value of serum sTREM (soluble triggering receptor expressed on myeloid cells)-1, sCD163, procalcitonin (PCT), C-reactive protein (CRP) concentrations, white blood cell (WBC) count and SOFA score during sepsis and their clinical informative value in predicting outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

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

September 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2011

Completed
Last Updated

July 7, 2011

Status Verified

July 1, 2010

Enrollment Period

1.8 years

First QC Date

July 5, 2011

Last Update Submit

July 6, 2011

Conditions

Keywords

sTREM-1sCD163PCTCRPWBC countSOFA scoreSIRSsepsisseverityprognosis

Outcome Measures

Primary Outcomes (1)

  • Patients Outcome

    The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death

    28 days

Study Arms (2)

SIRS

(1) temperature \> 38oC or \< 36oC; (2) pulse rate \> 90 beats/min; (3) ventilation rate \> 20 breaths/min or hyperventilation with a partial pressure of arterial carbon dioxide (PaCO2) \< 32 mmHg; (4) white blood cell (WBC) count \>1 2,000μL-1 or \< 4000 μL-1 , or \> 10% immature cells.

Sepsis

SIRS + infection

Eligibility Criteria

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

Between September 2009 and July 2011, inpatients were included who were in the intensive care units (ICU) of the Department of Respiratory Disease, the Emergency Department, and the Department of Surgery of the Chinese People's Liberation Army General Hospital.

You may qualify if:

  • Male and female aged 18 years old and over;
  • Clinically suspected infection;
  • Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °C or lower than 36 °C (b)respiratory rate above 20/min, or PCO2 below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.

You may not qualify if:

  • Those who fulfilled one below:
  • neutropenia (≤ 500 neutrophils/mm3)
  • HIV infection, and
  • patients or their relatives refused

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Systemic Inflammatory Response SyndromeSepsis

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockInfections

Study Officials

  • Xie Lixin, Doctor

    Department Of Respiratory Diseases, Chinese PLA General Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 7, 2011

Study Start

September 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 7, 2011

Record last verified: 2010-07

Locations