NCT01708759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

3 months

First QC Date

October 12, 2012

Last Update Submit

April 6, 2014

Conditions

Keywords

Serum Il-8IL8 polymorphismcritically ill patients

Outcome Measures

Primary Outcomes (1)

  • Serum Interlukin-8

    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.

    At intensive care admission. Patients will be followed for at least 2 weeks

Secondary Outcomes (1)

  • Interlukine-8polymorphism at 251 A/t

    At ICU admission. Patients will be followed for at least 2weeks.

Study Arms (2)

Sepsis

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

SIRS

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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).

You may qualify if:

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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine ,Tanta University.

Tanta, Algharbiya, 35217, Egypt

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

SepsisSystemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

InfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Ayman A Yousef, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anesthesiology

Study Record Dates

First Submitted

October 12, 2012

First Posted

October 17, 2012

Study Start

November 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations