IL8 Monitoring and Its Correlation With 251-gene Polymorphism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ayman Abd Al-maksoud Yousef, Tanta University
ClinicalTrials.gov Identifier:
NCT01708759
First received: October 12, 2012
Last updated: April 6, 2014
Last verified: April 2014
  Purpose

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.


Condition
Sepsis
Systemic Inflammatory Response Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Value of Admission Serum Il-8 Monitoring and the Detection of IL8 (-251 A/T) Polymorphism in Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by Tanta University:

Primary Outcome Measures:
  • Serum Interlukin-8 [ Time Frame: At intensive care admission. Patients will be followed for at least 2 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Interlukine-8polymorphism at 251 A/t [ Time Frame: At ICU admission. Patients will be followed for at least 2weeks. ] [ Designated as safety issue: Yes ]
    About 4ml blood is withdrawn in EDTA-tubes and the genomic DNA was extracted.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.


Enrollment: 80
Study Start Date: November 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sepsis
Forty patients developed septic complication during ICU stay (sepsis group).
SIRS
Forty patients were critically ill without evidence of infectious organism (SIRS group).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

A total of eighty African patients (47men and 33 women) were included in the study. Forty patients developed septic complication during ICU stay (sepsis group). Forty patients were critically ill without evidence of infectious organism (SIRS group).

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 .

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01708759

Locations
Egypt
Faculty of Medicine ,Tanta University.
Tanta, Algharbiya, Egypt, 35217
Sponsors and Collaborators
Tanta University
Investigators
Principal Investigator: Ayman A Yousef, MD Assistant professor os Anesthesia and ICU, Faculty of Medicine, Tanta university
  More Information

No publications provided

Responsible Party: Ayman Abd Al-maksoud Yousef, Assistant professor of Anesthesiology, Tanta University
ClinicalTrials.gov Identifier: NCT01708759     History of Changes
Other Study ID Numbers: 1380/09/12
Study First Received: October 12, 2012
Last Updated: April 6, 2014
Health Authority: Egypt: Institutional Review Board

Keywords provided by Tanta University:
Serum Il-8
IL8 polymorphism
critically ill patients

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on October 01, 2014