The effect of hydrocortisone , vitamin C, and thiamine for treatment of patients with septic shock addmited to intensive care unit of Ayatollah Mousavi hospital in Zanjan , in 2017-18
The effect of hydrocortisone, vitamin C, and thiamine for treatment of patients with septic shock admitted to intensive care unit(ICU) of Ayatollah Mousavi hospital in Zanjan between 2017 and 18
Design
Fifty eight patients with diagnosis of septic shock who admitted to intensive care unit (ICU) were divided into intervention and control group with simple randomization method.
Settings and conduct
In addition to routine sepsis treatment protocol,patients with septic shock admitted to intensive care unit of Ayatollah Mousavi hospital in Zanjan were treated by combination of hydrocortisone ,vitamin C and thiamine for 72 hours in intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with septic shock and equal APACHE II score hospitalized in intensive care unit(ICU)
Intubated patients
Patients between 18 years and 70
PCT level more than 2 ng/dl
Non inclusion criteria:
Pregnant patients
Intervention groups
Twentynine patients with diagnosis of septic shock were treated with intravenous combination of Hydrocortisone, vitamin C, Thiamine for seventy two hours and twonty nine patients in control group treated by standard septic shock treatment guideline.
The effect of hydrocortisone , vitamin C, and thiamine for treatment of patients with septic shock addmited to intensive care unit of Ayatollah Mousavi hospital in Zanjan , in 2017-18
Public title
The effect of hydrocortisone, vitamin C, and thiamine for treatment of septic shock
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with septic shock and the same Acute Physiology, Age, chronic health evaluation II (APACHE II score) admitted to intensive care unit
Intubated patients
Age between 18 to 70 years
Serum pro-calcitonin level ≥ 2ng/ml.
Exclusion criteria:
Pregnant patients
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
58
Actual sample size reached:
58
Randomization (investigator's opinion)
Randomized
Randomization description
In this study patients who met inclusion criteria were divided into intervention and control group by simple randomization method. Fiftyeghit patients with diagnosis of septic shock in critical care unit of ayatollah mousavi hospital after matching for demographic data’s and Apache 2 Score we’re divided into intervention group and control group by randomization with computerized random number tables.This method is one of basic methods for sampling in experimental studies, and frequently is used in studies with a few sample size.For randomization between two groups, random numbers table is used.In this study fiftyeghit patients with diagnosis of septic shock in critical care unit of ayatollah mousavi hospital after matching for demographic data’s and Apache 2 Score we’re divided into intervention group and control group by randomization with computerized random number tables.Fifty eight random numbers were extracted of computer by using random number table and for example 24th sample was set in intervention group and 14th sample was set in control group and this process was performed until end of the study.
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 Zanjan University of Medical Sciences
Street address
Mousavi hospital,Sobotie Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.ZUMS.REC.1397.041
Health conditions studied
1
Description of health condition studied
Septic shock
ICD-10 code
R65.21
ICD-10 code description
Severe sepsis with septic shock
Primary outcomes
1
Description
The Sequential organ function assessment (SOFA) score:a factor for evaluation of organ function
Timepoint
One day Later-Three days Later
Method of measurement
SOFA table was used to measure the performance of the organs.
2
Description
Serum lactate( a factor for evaluation of Oran perfusion)
Timepoint
One day Later-Three days Later
Method of measurement
Lactate measurement kit was used to measure lactate.
3
Description
WBC count(leukocyte Count as a factor for evaluation of sepsis progression)
Timepoint
One day Later-Three days Later
Method of measurement
Cell counters were used to measure the number of white blood cells.
4
Description
Need for vasopressors (definition of septic shock is sepsis which requires treatment with vasopressors)
Timepoint
One day later-Three days later
Method of measurement
For measuring the vasopressors, the average pressure is used, the unit is micrograms per minute.
5
Description
Serum procalcitonin (indicator of sepsis severity)
Timepoint
One day later-Three days later
Method of measurement
The measure of procalcitonin was VIDAS B.R.A.M.S PCT assy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group has received the assessed combination therapy, including hydrocortisone (50mg/each 6h, intravenously), vitamin C (1.5g/6h in 100ml DW5%, intravenously), and thiamine (200mg/12h in 50ml DW5%, intravenously)in addition to standard septic shock treatment protocols for seventy two hours.
Category
Treatment - Drugs
2
Description
Control group: This group has treated by standard septic shock treatment protocols including antibiotic therapy, prophylaxis of deep venous thrombosis, sedative medications, mechanical ventilation and prescription of vasopressor without additional intervention .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi hospital
Full name of responsible person
Mohammadreza Jamshidi
Street address
Ayatollah Mousavi Hospital, Sobotie Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1419
Email
jamshidianes@zums.ac.ir
Web page address
http://www.zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza shoghli
Street address
Azadi Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3322 4766
Fax
+98 24 3322 4766
Email
research@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=3
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Jamshidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mousavy Hospital, Sobotie Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
jamshidianes@zums.ac.ir
Web page address
http://www.zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Jamshidi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Zanjan,Gavazang Ave ,Mousavy Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
jamshidianes@zums.ac.ir
Web page address
http://www.zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Zeraati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Critical care medicine
Street address
Ayatollah Mousavy Hospital, Sobotie Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
mohammadrezazeraati@zums.ac.ir
Web page address
http://www.zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the end of study,We will share non-identifiable individual data of the participants, the study protocol, the statistical analysis of the data, the informed consent form patients,clinical reports, analysis codes, and data coding systems (data Dictionary) .
When the data will become available and for how long
We will share our study results in 2019.
To whom data/document is available
The data from this study will be available to all people who can play a role in caring of septic patients, such as families, and healthcare workers.
Under which criteria data/document could be used
The results of this study will be useful for care providers especially involving in septic patients admitted to intensive care units.
From where data/document is obtainable
To receive information anyone can be use the following email: jamshidianes@zums.ac.ir
What processes are involved for a request to access data/document
we will send the results of our study to the applicants .