NCT01847248

Brief Summary

  • Molecules indicating endothelial injury may serve as biomarkers for severe sepsis because of the critical role of endothelial injury in organ dysfunction during severe sepsis.
  • HSPA12B is primarily located in endothelial cells and detectable during sepsis.
  • The investigators speculated that HSPA12B from endothelial cells might be correlated with severe sepsis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2011

Typical duration 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

May 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1.8 years

First QC Date

May 2, 2013

Last Update Submit

November 22, 2013

Conditions

Sepsis

Keywords

sepsisbiomarkerHSPA12B

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    mortality within 28 days after recruitment.

    28 days

Study Arms (4)

sepsis

Patients with sepsis but not severe sepsis

Severe sepsis

Patients with severe sepsis

SIRS

Patients with SIRS after major orthopedics surgery

Control

Healthy volunteers

Eligibility Criteria

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

Continuous patients with sepsis, severe sepsis, SIRS after major orthopedics surgery and healthy volunteers

You may qualify if:

  • Adult patients
  • Patients meet the diagnostic criteria according to the grouping

You may not qualify if:

  • patients without informed consent
  • patients who were undergoing continuous renal replacement therapy before sampling
  • patients with special infection induced by virus, tubercle bacillus, mycoplasma, Chlamydia, and so on

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Changhai Hospital

Shanghai, 200433, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ke-ming Zhu, M.D.

    Department of Anesthesiology and Intensive Care Medicine, Changhai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 6, 2013

Study Start

May 1, 2011

Primary Completion

March 1, 2013

Study Completion

October 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

CN(1)