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

• Conditions: Systemic Inflammatory Response Syndrome; Sepsis

• Registration Number: NCT01838525
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-04
• Status Verified: 2013-04
• Study First Submitted: 2013-04-19
• Study First Submitted QC: 2013-04-23
• Last Update Submitted: 2013-04-23
• Study First Posted: 2013-04-24
• Last Update Posted: 2013-04-24
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients Outcome	28 days	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

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China