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

NCT01838525 | Unknown DMC

• 1 other identifier: 20130419-007
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Systemic Inflammatory Response Syndrome; Sepsis

Keywords

sepsis; alpha-1-acid glycoprotein (AGP); diagnosis; prognosis; SIRS

Outcome Measures

Primary Outcomes (1)

• Patients Outcome

  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

  28 days

Study Arms (3)

SIRS, SEPSIS

sepsis, severe sepsis, septic shock

health, SIRS, Sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Between April 2011 and APRIL 2013, inpatients were included who were in the intensive care units (ICU) of the Department of Respiratory Disease (RICU), the Emergency Department (EICU), and the Department of Surgery (SICU) of the Chinese People's Liberation Army General Hospital.

You may qualify if:

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

You may not qualify if:

• less than 18 years old;
• immunosuppression;
• agranulocytosis (granulocyte counts \<0.5× 109/L);
• chronic myeloid leukemia (CML);
• malignancy;
• less than 24 hours of the length of ICU stay;
• reluctant to participate in the study.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 25957497 DERIVED

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Sepsis; Disease

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Infections

Study Officials

• Lixin Xie, doctor

  Department Of Respiratory Diseases, Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Kun Xiao, graduate

CONTACT

+86 13716608331; xiaok301@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: April 24, 2013
• Study Start: April 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

CN (1)