Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-27 @ 2:10 AM
Study NCT ID:
NCT01708759
Status:
COMPLETED
Last Update Posted:
2014-04-08
First Post:
2012-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IL8 Monitoring and Its Correlation With 251-gene Polymorphism
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
The Value of Admission Serum Il-8 Monitoring and the Detection of IL8 (-251 A/T) Polymorphism in Critically Ill Patients
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: