NCT01494389

Brief Summary

The purpose of this study is to explore the value of CD4+T lymphocyte subsets in cell immunity in the patients with sepsis.There are immunoparalysis in septic patients,the important player is the change of CD4+T lymphocyte,this immunoparalysis state contribute to the illness progress and outcome. Comprehend the change regularity of septic patients' cell immunity can guide fiter and correcter treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2011

Shorter than P25 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

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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

December 16, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 19, 2011

Status Verified

July 1, 2011

Enrollment Period

7 months

First QC Date

December 16, 2011

Last Update Submit

December 16, 2011

Conditions

Keywords

CD4+T lymphocyte subsetssepsisimmunoparalysis

Study Arms (3)

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

Normal

not SIRS and have no infection

Eligibility Criteria

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

All subjects were selected from among inpatients who were hospitalized between March 2010 and March 2011 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.

You may qualify if:

  • Male and female aged 18 years old and over;
  • 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.
  • Clinically suspected infection;

You may not qualify if:

  • were under 18 years of age;
  • were refused by the patients or his/her familiality;
  • were suffering from acquired immunodeficiency syndrome,virlhepatitis,autoimmune diseases and hematology;
  • use medicine which can affect immune system,such as Glucocorticoid and Immunosuppressant
  • died within 24h after being taken into the ICU, or refused to get involved in the study, or gave up treatment during the period of observation

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

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xie Li Xin, 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

December 16, 2011

First Posted

December 19, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

December 19, 2011

Record last verified: 2011-07

Locations