Protocol summary

Summary
Introduction: Early detection of sepsis is one of the important aspects of today’s emergency care. The availability of antibiotics has improved the patient care, but early diagnosis and correct antibiotic selection is still a challenge. Procalcitonin is one of the latest sepsis bio-markers, which have shown to be useful in tracking the course of sepsis and antibiotic response. The aim of this study is to determine the feasibility of using procalcitonin readings in early prediction, before the antibiogram results are available (first 48 hours), in patients with sepsis coming to emergency department. Patients and Methods: The study is a prospective randomized clinical trial conducted in Imam Hossein Medical Center emergency department, Tehran, Iran. All patients with clinical findings suggesting sepsis or systemic inflammatory response syndrome who give consent will enter the study. Patients with systemic inflammation of non bacterial origin, viral or parasitic infections, patients who receive corticosteroids on immunosuppressive drugs will be excluded. Also all patients with a history of immunodeficiency or central venous catheter will be excluded. The sampling continues until 150 patients are entered into the study. A predesigned questionnaire will be used to document the patients’ clinical findings. Peripheral blood sample for culturing and antibiogram and procalcitonin measurement, as well as other routine laboratory tests will be taken. The procalcitonin levels will be checked before, six, and twenty four hours after the initiation of antibiotic therapy. The procalcitonin measurement will be done using immunoluminometric measuring (Brahms PCT, Diasorin, USA). We will not interfere with any aspects of treatment and antibiotic therapy. Antibiotic change, if necessary, will be carried on based on patients’ clinical findings and ultimately based on antibiogram. The results of procalcitonin readings will be compared to blood culture, urine culture, CSF cultures and antibiogram results, clinical findings and patients’ outcome. We will calculate the sensitivity and specificity of procalcitonin in predicting the antibiotic response compared to antibiogram as the gold standard.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102065774N1
Registration date: 2011-07-24, 1390/05/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-07-24, 1390/05/02
Registrant information
Name
Ali Arhami Dolatabadi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8825 1234
Email address
ali_arhami@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of procalcitonin level measurement in diagnosis of early antimicrobial resistance in patient with sepsis in emergency department
Public title
The role of procalcitonin in sepsis
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: All patients with clinical findings suggesting sepsis, All patients with clinical findings of systemic inflammatory response syndrome Exclusion criteria: All patients with clinical findings of systemic inflammatory response syndrome from non bacterial origin, viral or parasitic infections, patients who receive corticosteroids on immunosuppressive drugs, history of immunodeficiency, patient with central venous catheter and premature infant
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Scinces
Street address
Tabnank St, Yaman St, Shahid Chamran highway
City
Tehran
Postal code
1985717443
Approval date
2011-02-27, 1389/12/08
Ethics committee reference number
96

Health conditions studied

1

Description of health condition studied
Sepsis
ICD-10 code
B90-B94
ICD-10 code description
Sequelae of infectious and parasitic diseases

2

Description of health condition studied
procalcitonin
ICD-10 code
R70-R79
ICD-10 code description
Abnormal findings on examination of blood, without diagnosis

Primary outcomes

1

Description
procalcitonin
Timepoint
before and 6 hr and 24 hr after empiric antibiotic administration
Method of measurement
Immunoluminoassay ng/mL

Secondary outcomes

1

Description
Antibiogram
Timepoint
One time
Method of measurement
Resistantant, sensitive

2

Description
Empiric antibiotic
Timepoint
one time, after blood sampling withdrawn
Method of measurement
based on united state infectious disease guideline

3

Description
Time of clinical sign improved
Timepoint
Daily
Method of measurement
Clinical sign(fever)

4

Description
Prognosis(death)
Timepoint
Death
Method of measurement
Clinically

5

Description
Prognosis(life)
Timepoint
Life
Method of measurement
Clinically

6

Description
Thyroid tumor
Timepoint
One time
Method of measurement
Clinical and laboratory investigation

7

Description
Immunosuppression
Timepoint
One time
Method of measurement
Clinical and laboratory investigation

Intervention groups

1

Description
Immunoluminoassy of serum procalcitonin in patient with sepsis, Blood sampling, Lumbar puncture
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Immam Hosein hospital
Full name of responsible person
Ali Arhami Dolatabadi
Street address
Shahid Madani St, Immam Hosein hospital,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice-chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Rahmati Roodsari
Street address
Tabnak St, Yaman St, Shahid Chamran highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice-chancellor for research of Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Arhami Dolatabadi
Position
Emergency medicin, Assistant professor
Other areas of specialty/work
Street address
Shahid Madani St, Immam hosein hospital
City
Tehran
Postal code
1617763141
Phone
00982177558081- 00982188251234
Fax
00982177557069-00982188280102
Email
ali_arhami@sbmu.ac.ir; aliarhami@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Arhami Dolatabadi
Position
Emergency medicine, Assistant professor
Other areas of specialty/work
Street address
Shahid Madani St, Immam Hosein hospital
City
Tehran
Postal code
1617763141
Phone
00982177558081-00982188251234
Fax
00982177557069-00982188280102
Email
ali_arhami@sbmu.ac.ir; aliarhami@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Arhami Dolatabadi
Position
Emergency medicine, Assistant professor
Other areas of specialty/work
Street address
Shahid Madani St, Immam Hosein hospital
City
Tehran
Postal code
1617763141
Phone
+98 21 7755 8081
Fax
00982177557069-00982188280102
Email
ali_arhami@sbmuy.ac.ir; aliarhami@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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