NCT01504243

Brief Summary

CD163 is a member of the scavenger receptor cysteine-rich family (SRCR) is exclusively expressed on cells of the monocyte lineage.CD163 acts to amplify inflammation and serves as a critical mediator of inflammatory response in the context of sepsis. This study was designed to investigate whether CD163 genomic variations were associated with the prognosis of sepsis. We sequenced 30 sepsis patients with CD163 gene of seventeen exons by PCR sequencing. When analyzing the results of sequencing, we found five gene polymorphisms located in exon-2,exon-5 and exon-11, respectively. Compare with the NCBI dbSNP and Hapmap database, one polymorphisms located in exon-2 is non-synonymous variation rs3210140, two polymorphisms located in exon-5 are synonymous variations rs4883264 and rs4883263, the last two located in exon-11 are synonymous variations rs61729512 and rs150018775 . Five common polymorphisms (rs2234237,rs2234246) within the CD163 gene were detected in 200 patients with severe sepsis and in 200 healthy control subjects. This study was explored that whether or not polymorphisms detected within the CD163 gene may play a major role in the predisposition to prognosis of sepsis in a Chinese Han cohort.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

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

May 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 5, 2012

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

January 4, 2012

Last Update Submit

January 4, 2012

Conditions

Keywords

CD163;SNPs;prognosis;control(normal person)

Study Arms (2)

Control

normal person under medical examination

sepsis

SIRS plus inflammation

Eligibility Criteria

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

All subjects were selected from among inpatients who were hospitalized between September 2009 and October 2011 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.

You may qualify if:

  • Sepsis met the criteria recommended by 1991 ACCP/SCCM Joint Meeting and by the diagnostic criteria developed at the 2001 International Sepsis Definition Conference.

You may not qualify if:

  • (1) younger than 18 years of age; (2) acquired immunodeficiency syndrome; (3) reduced polymorphonuclear granulocyte counts (\< 500 μL-1); (4) died within 24h after admission into the ICU, or refused to participate in the study, or declined 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, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Li xin Xie, MD

    Respiratory Disease Department of chinese PLA General Hospital

    STUDY DIRECTOR

Central Study Contacts

Zhao xv Jiang, Ms

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 5, 2012

Study Start

May 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

January 5, 2012

Record last verified: 2011-12

Locations