IL8 Monitoring and Its Correlation With 251-gene Polymorphism

Completed

• Conditions: Sepsis; Systemic Inflammatory Response Syndrome

• Registration Number: NCT01708759
• Lead Sponsor: Tanta University

Brief Summary

One hundred eighty critically ill African adult intensive care patients divided into two groups, eighty septic critically ill patients (sepsis group) while, eighty non-septic critically ill patients (SIRS) group. Admission serum IL-8 was measured in both sepsis and SIRS groups. IL-8 (-251A/T) polymorphism was detected in sepsis and SIRS groups.

Detailed Description

A total of one hundred eighty African patients (97men and 83 women) were included in the study. Eighty patients developed septic complication during ICU stay (sepsis group). Eighty patients were critically ill without evidence of infectious organism (SIRS group). Patients received anti-inflammatory drugs or corticosteroids before admission, who had immunosuppressive illness, who had chronic organ failure; who had received massive blood transfusion; those with radiation therapy, previous organ transplantation were excluded from the study. At admission, the patient's age, sex, height and weight were recorded. These data include the following: clinical status; sequential organ failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure; central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis. Routine cultures of blood, urine and suspected sites were obtained to determine the presence of infection. We attempted to maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o. If needed, blood products, intravascular fluid replacement and inotropic and/or vasopressor agents were administered. Each day the attending physician in the ICU evaluated all the study patients for sepsis, severe sepsis, or septic shock.

Study Timeline

• Study First Submitted: 2012-10-12
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-17
• Study Start: 2012-11
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-06
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Adults patients with clinical diagnosis of sepsis or systemic inflammatory response syndrome.

Exclusion Criteria

Patients received anti-inflammatory drugs or corticosteroids before admission, patients who had immunosuppressive illness ie. AIDS, patients with chronic liver failure, patients with renal failure, patients with respiratory failure ; patients received massive blood transfusion; patients with radiation therapy, patients with organ transplantation .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum Interlukin-8	At intensive care admission. Patients will be followed for at least 2 weeks	Serum level of IL-8 was determined by quantitative sandwich enzyme immunoassay (R\&D Systems, Inc., Minneapolis, MN, USA) according to the manufacturer's instructions. The intensity of the colour was measured at 490 nm for IL-8.

Secondary Outcome Measures

Name	Time	Method
Interlukine-8polymorphism at 251 A/t	At ICU admission. Patients will be followed for at least 2weeks.	About 4ml blood is withdrawn in EDTA-tubes and the genomic DNA was extracted. Concentration of the extracted DNA was then measured by UV spectrophotometry at 260\& 280 nm and run on agaros gel electrophoresis 2% for detection of purity. Molecular detection of the (-251 A/T) polymorphism in the IL-8gene was achieved by restriction fragment length polymorphism typing.

Trial Locations

Locations (1)

Faculty of Medicine ,Tanta University.; 🇪🇬 Tanta, Algharbiya, Egypt