IL8 Monitoring and Its Correlation With 251-gene Polymorphism

NCT ID: NCT01708759

Last Updated: 2014-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-02-28

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.

Conditions

Sepsis; Systemic Inflammatory Response Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Sepsis

Forty patients developed septic complication during ICU stay (sepsis group).

No interventions assigned to this group

SIRS

Forty patients were critically ill without evidence of infectious organism (SIRS group).

No interventions assigned to this group

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ayman Abd Al-maksoud Yousef

Assistant professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayman A Yousef, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor os Anesthesia and ICU, Faculty of Medicine, Tanta university

Locations

Faculty of Medicine ,Tanta University.

Tanta, Algharbiya, Egypt

Countries

Egypt

References

Sutherland A M, Russell J A. Issues with polymorphism analysis is sepsis. Clinical infectious diseases 2005; 41; S369-402. Winning J, Claus RA, Huse K, Bauer M. Molecular biology on the ICU from understanding to treating sepsis. Minerva Anestesiol 2006; 72:255-67. Hull J, Thomson A, Kwiatkowski D:Association of respiratory syncytial virus broncholitis with the interleukin-8 gene region in UK families. Thorax 2000, 55: 1023-1027. Gyulai Z, Klausz G, Tiszai A, Lenart Z, Kasa IT, Lonovics J, Mandi Y. Genetic polymorphism of interleukin-8 (IL-8) is associated with Helicobacter pylori induced duodenal ulcer. Eur Cytokine Netw 2004, 15:353-358.

Reference Type: BACKGROUND

Other Identifiers

1380/09/12

Identifier Type: -

Identifier Source: org_study_id