Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000504819
Ethics application status
Approved
Date submitted
8/05/2012
Date registered
10/05/2012
Date last updated
10/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examination of Relationship Between Bilirubin with cytokines and Scores Used as a Marker of Mortality in Patients with Sepsis
Scientific title
The Association of Bilirubin with IL-6, IL-10 and Mortality Scores of Patients with Sepsis
Secondary ID [1] 280459 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis 286436 0
Condition category
Condition code
Infection 286693 286693 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1)The patients were classified into two groups:
one group, patients diagnosed with sepsis according to the American College of Chest Physicians/Society of Clinical Care Medicine (ACCP/SCCM) consensus conference criteria,
other group, patients being treated with a non-sepsis disease in ICU.
2)Blood samples were taken at three time intervals: the time of origin (defined as the day of sepsis diagnosis), 24 hours after diagnosis, and 48 hours after diagnosis.
3)APACHE II (Acute Physiology and Chronic Health Evaluation) and SOFA (Sepsis Related Organ Failure Score) scores were recorded at three time intervals: the time of origin (defined as the day of sepsis diagnosis), 24 hours after diagnosis, and 48 hours after diagnosis.
Intervention code [1] 284822 0
Not applicable
Comparator / control treatment
During study, it was elected from patients who treated with a non-sepsis reason in ICU and ventilated mechanically.
blood samples were taken at the same periods and were recorded mortality scores.
Control group
Active

Outcomes
Primary outcome [1] 287088 0
serum bilirubin (Direct, indirect, total) levels
Timepoint [1] 287088 0
at the time of origin (defined as the day of sepsis diagnosis),
24 hours after diagnosis,
48 hours after diagnosis
Primary outcome [2] 287089 0
serum IL-6, IL-10 levels
Timepoint [2] 287089 0
at the time of origin (defined as the day of sepsis diagnosis),
24 hours after diagnosis,
48 hours after diagnosis
Secondary outcome [1] 297346 0
APACHE score,
Timepoint [1] 297346 0
at the time of origin (defined as the day of sepsis diagnosis),
24 hours after diagnosis,
48 hours after diagnosis
Secondary outcome [2] 297360 0
SOFA score
Timepoint [2] 297360 0
at the time of origin (defined as the day of sepsis diagnosis),
24 hours after diagnosis,
48 hours after diagnosis

Eligibility
Key inclusion criteria
20 ICU patients diagnosed with sepsis (according to the American College of Chest Physicians/Society of Clinical Care Medicine (ACCP/SCCM) consensus conference criteria) or other diseases
the ages of 18 and 75
receiving mechanical ventilation (SIMV, VT: 6-8 ml/kg, f: 12-14, I/E: 1/2).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of hepatobiliary diseases, jaundice, HBV/HCV sero positivity, renal failure, drug overdose, hemolytic anemia, hypoxia, severe hemodynamic instability, and/or possible brain death were excluded.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 4295 0
Turkey
State/province [1] 4295 0

Funding & Sponsors
Funding source category [1] 285218 0
University
Name [1] 285218 0
FIRAT UNIVERSITY SCIENTIFIC RESEARCH PROJECTS UNIT
Country [1] 285218 0
Turkey
Primary sponsor type
University
Name
Firat University Scientific Research Projects Unit
Address
Firat University Scientific Research Projects Unit
Firat University
23119 Elazig
Country
Turkey
Secondary sponsor category [1] 284089 0
None
Name [1] 284089 0
Address [1] 284089 0
Country [1] 284089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287222 0
Firat University Medical School Ethical Evaluation Commission Chairman
Ethics committee address [1] 287222 0
Firat University Medical School Ethical Evaluation Commission Chairman
Firat University
23119,Elazig
Ethics committee country [1] 287222 0
Turkey
Date submitted for ethics approval [1] 287222 0
04/05/2010
Approval date [1] 287222 0
03/06/2010
Ethics approval number [1] 287222 0

Summary
Brief summary
Purpose: Bilirubin has been shown to influence the mechanisms of both apoptosis and inflammation. We investigated the association of bilirubin with sepsis progression.
Materials and Methods: Twenty patients from Intensive Care Unit (ICU) were recruited for this study. Patients were divided into two groups: patients diagnosed with sepsis according to the ACCP/SCCM consensus conference criteria (n=10) and patients treated for various other diagnoses (n=10). Blood samples were collected for both groups at the time of origin (defined as the time of diagnosis), and 24 and 48 hours after diagnosis. Serum IL-6, IL-10 and bilirubin levels were analyzed and compared. APACHE II and SOFA scores of the patients were also recorded.
Results: At all time intervals, serum IL-6, IL-10, and total, direct, and indirect bilirubin were significantly higher in the sepsis group (p<0.05); APACHE II and SOFA scores were also significantly higher. Both SOFA scores and serum IL-10 levels were positively correlated with bilirubin levels 24 hours after diagnosis (p<0.05, r=-0.76).
Conclusion: Although levels of bilirubin and other associated parameters were higher for the sepsis group, only SOFA score and bilirubin levels were correlated. Because bilirubin is already a SOFA parameter, this correlation was not considered clinically significant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34153 0
Address 34153 0
Country 34153 0
Phone 34153 0
Fax 34153 0
Email 34153 0
Contact person for public queries
Name 17400 0
Ayse Belin OZER
Address 17400 0
Firat University Medicine Faculty
Anesthesiology and Reanimation Department
23119, Elazig
Country 17400 0
Turkey
Phone 17400 0
+90 424 533 4478924
Fax 17400 0
+90 424 2388096
Email 17400 0
abelinozer@gmail.com
Contact person for scientific queries
Name 8328 0
Ayse Belin OZER
Address 8328 0
Firat University Medicine Faculty
Anesthesiology and Reanimation Department
23119, Elazig
Country 8328 0
Turkey
Phone 8328 0
+90 424 533 4478924
Fax 8328 0
+90 424 2388096
Email 8328 0
abelinozer@gmail.com

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