The effect of prescribing an active form of vitamin D in the form of calcitriol on the markers of infection including procalcitonin and peresepsin in patients with positive systemic inflammatory responses that are candidates for intravenous antibiotics due to suspected infection according to the ICU practitioner.
Design
open labeled pilot study
Settings and conduct
positive SIRS patients of imam hussein hospital will be divided into intervention and control group and will be evaluated.
Participants/Inclusion and exclusion criteria
including citeria
Individuals over the age of 18 years who are clinically considered positive for SIRS (within the first 48 hours of diagnosis), based on the following criteria (if 2 of the 4 parameters are positive), and according to the ICU, the antibiotic team started for them Be:
1) The temperature is above 38 degrees or below 36 degrees Celsius
2) Heart rate above 90 beats per minute
3) The number of respiration above 20 or arterial carbon dioxide below 32 mm Hg
4) The number of white blood cells> 12000 or <4000
Exit criteria
1) Serum calcium ≥ 10 mg / dl or serum phosphate ≥ 6 mg / dl in the last 48 hours
2) Receiving vitamin D supplements with doses of more than 1000 units per day or calcitriol with each dose in the last week
3) history of diseases including primary parathyroidism, sarcoidosis, metabolic bone disease, and renal failure in the last stage
4) Pregnancy and lactation
5) Length of hospital stay in the ICU below 48 hours
Intervention groups
Patients were divided into two intervention and control groups. In the intervention group, patients received 1 microgram of venous calcitriol for 3 consecutive days but did not receive calcitriol in the control group.
Main outcome variables
level of serum procalcitonin and presepsin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180522039777N1
Registration date:2018-10-07, 1397/07/15
Registration timing:retrospective
Last update:2018-10-07, 1397/07/15
Update count:0
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
Farnoosh Masbough
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7743 3195
Email address
farnoosh.masbough@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2017-12-06, 1396/09/15
Actual recruitment end date
2018-07-11, 1397/04/20
Trial completion date
2018-07-11, 1397/04/20
Scientific title
Effect of calcitriol supplementation on infectious biomarkers including Procalcitonin and Presepsin with positive systemic inflammatory response
Public title
Effect of calcitriol in infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all positive SIRS patients greater than or equal to 18 years with suspicion to infection that antibiotics have been started for them
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
29
Randomization (investigator's opinion)
Randomized
Randomization description
random numbers table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti University of Medical Sciences
Street address
Vali asr Ave.down from the crossroads niayesh
City
Tehran
Province
Tehran
Postal code
1991953381
Approval date
2017-11-06, 1396/08/15
Ethics committee reference number
IR.SBMU.PHNM.1396.885
Health conditions studied
1
Description of health condition studied
positive systemic inflammatory response
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
improved in procalcitonin marker
Timepoint
Marker measurements at day 0, 3 and 5 after calcitriol injection
Method of measurement
Reduce symptoms of inflammation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam hossein hospital
Full name of responsible person
farnoosh masbough
Street address
Emam Hossein Hosp. - Madani St. - Tehran - Iran
City
tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7759 0148
Email
info@ehmc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
tahereh shams
Street address
velenjak street, shahid chamran high way
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
mohammad sistanizad
Position
assistant professor, clinical pharmacy specialist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
department of clinical pharmacy, faculty of pharmacy, niayesh highway
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 0118
Email
sistanizadm@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
mohammad sistanizad
Position
assistant of professor, clinical pharmacy specialist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
department of clinical pharmacy, faculty of pharmacy, Niayesh highway
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 0118
Email
sistanizadm@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
farnoosh masbough
Position
دانشجوی داروسازی
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
vali-e-asr St, Niayesh
City
tehran
Province
Tehran
Postal code
1766685491
Phone
+98 21 7743 3195
Email
farnoosh.masbough@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD