Alpha-1-acid Glycoprotein as a Biomarker of Developmental Diagnosing and Monitoring Effectiveness in Sepsis

NCT ID: NCT01838525

Last Updated: 2013-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-06-30

Brief Summary

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To assess the potential value of alpha-1-acid glycoprotein (AGP) for early diagnosis and prognosis of patients with sepsis, and then compared with C-reactive protein (CRP), procalcitonin (PCT), white blood cell (WBC) counts, Acute Physiology and Chronic Health Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score. 164 patients were enrolled in the study, including 25 cases with systemic inflammatory response syndrome (SIRS) and 139 cases with different levels of sepsis (46 moderate sepsis, 52 severe sepsis and 41 septic shock ). Serum levels of Alpha-1-acid Glycoprotein (AGP), C-reactive protein (CRP), and procalcitonin (PCT), and white blood cell (WBC) counts were measured on the day of admission to intensive care unit (ICU).

Detailed Description

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Conditions

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Systemic Inflammatory Response Syndrome Sepsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SIRS, SEPSIS

No interventions assigned to this group

sepsis, severe sepsis, septic shock

No interventions assigned to this group

health, SIRS, Sepsis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Male and female aged 18 years old and over;
2. Clinically suspected infection;
3. 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;

Exclusion Criteria

1. less than 18 years old;
2. immunosuppression;
3. agranulocytosis (granulocyte counts \<0.5× 109/L);
4. chronic myeloid leukemia (CML);
5. malignancy;
6. less than 24 hours of the length of ICU stay;
7. reluctant to participate in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Longxiang Su

Attending Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lixin Xie, doctor

Role: STUDY_DIRECTOR

Department Of Respiratory Diseases, Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kun Xiao, graduate

Role: CONTACT

+86 13716608331

Facility Contacts

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Lixin Xie, doctor

Role: primary

+86 010 55499130

References

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Xiao K, Su L, Yan P, Han B, Li J, Wang H, Jia Y, Li X, Xie L. alpha-1-Acid glycoprotein as a biomarker for the early diagnosis and monitoring the prognosis of sepsis. J Crit Care. 2015 Aug;30(4):744-51. doi: 10.1016/j.jcrc.2015.04.007. Epub 2015 Apr 17.

Reference Type DERIVED
PMID: 25957497 (View on PubMed)

Other Identifiers

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20130419-007

Identifier Type: -

Identifier Source: org_study_id

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