SepsisNCT01708759
IL8 Monitoring and Its Correlation With 251-gene Polymorphism
An observational study of Sepsis and Systemic Inflammatory Response Syndrome, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sepsis, Systemic Inflammatory Response Syndrome
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2012to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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).
Who may be able to join
- Adults patients with clinical diagnosis of sepsis or systemic inflammatory response syndrome.
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Admission Serum Il-8 Monitoring and the Detection of IL8 (-251 A/T) Polymorphism in Critically Ill Patients
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.
Read the 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
- Keywords
- Serum Il-8, IL8 polymorphism, critically ill patients
- Medical subject headings
- Sepsis, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Forty patients developed septic complication during ICU stay (sepsis group). | |
| SIRS | Forty patients were critically ill without evidence of infectious organism (SIRS group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At intensive care admission. Patients will be followed for at least 2 weeks
Secondary outcomes (1)
Interlukine-8polymorphism at 251 A/t
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.
Measured: At ICU admission. Patients will be followed for at least 2weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Abd Al-maksoud Yousef, Tanta University
- Investigators
- Ayman A Yousef, MD, Principal investigator, Assistant professor os Anesthesia and ICU, Faculty of Medicine, Tanta university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708759
- Sponsor's protocol ID
- 1380/09/12
- Status last verified
- Apr 2014
- First submitted
- 12 Oct 2012
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 Oct-Dec;15(4):353-8.
PubMed 15627645
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Admission Serum Il-8 Monitoring and the Detection of IL8 (-251 A/T) Polymorphism in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01708759
- Acronym / sponsor ID
- 1380/09/12
- Conditions
- Sepsis, Systemic Inflammatory Response Syndrome
- Keywords
- Serum Il-8, IL8 polymorphism, critically ill patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | –Forty patients developed septic complication during ICU stay (sepsis group). |
| SIRS | – | –Forty patients were critically ill without evidence of infectious organism (SIRS group). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (1 listed)
- Adults patients with clinical diagnosis of sepsis or systemic inflammatory response syndrome.
Key exclusion criteria (1 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Interlukin-8
Time frame: 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.
1 secondary outcome
Interlukine-8polymorphism at 251 A/t
Time frame: At ICU admission. Patients will be followed for at least 2weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Background: PubMed 15627645Gyulai 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 Oct-Dec;15(4):353-8.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman A Yousef, MD principal investigator
Assistant professor os Anesthesia and ICU, Faculty of Medicine, Tanta university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Systemic Inflammatory Response Syndrome, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Interlukin-8 (time frame: At intensive care admission. Patients will be followed for at least 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01708759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.