Protocol summary

Study aim
Investigate the effectiveness of infusion of high-dose ascorbic acid and thiamine as an auxiliary treatment on the clinical implications of severe sepsis patients admitted to intensive care unit
Design
Participants will be randomly divided into intervention and control groups and each participant will be assigned a code.
Settings and conduct
This study will be at the Imam Reza Hospital in Kermanshah by a resident researcher. First, the conditions for admission to the study are clearly explained to the patient or his legal guardian, and if the consent form is desired, he will be informed. This study will be conducted as a blind and patients are not aware that in the intervention group or a control group.
Participants/Inclusion and exclusion criteria
Dysfunction of organs and SOFA score ≥ 2 in patients whose antibiotic therapy is diagnosed
Intervention groups
The intervention group will receive 50 mg intravenous ascorbic every 6 hours and up to 6 grams and 200 mg thiamine every 12 hours for 4 days
Main outcome variables
organ dysfunction Length of stay in ICU Mortality rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130812014333N78
Registration date: 2017-12-03, 1396/09/12
Registration timing: prospective

Last update: 2017-12-03, 1396/09/12
Update count: 0
Registration date
2017-12-03, 1396/09/12
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kermanshah University of Medical Sciences
Expected recruitment start date
2017-12-06, 1396/09/15
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness and non effectiveness of infusion of high-dose ascorbic acid and thiamine as an auxiliary treatment on the clinical implications of severe sepsis patients admitted to ICU
Public title
The effectiveness of infusion of ascorbic acid and thiamine on the clinical implications of severe sepsis patients admitted to ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dysfunction of organs and SOFA score ≥ 2 in patients whose antibiotic therapy is diagnosed. SOFA score ≥ 2 in patients whose antibiotic therapy is diagnosed.
Exclusion criteria:
Pregnant women and people under the age of 18; ; Allergy to ascorbic acid, Chronic hemodialysis, Hemochromatotomy Sickness to G6PD Nephropathy oxalate or bilateral erlithiasis Receive simultaneously other antioxidants Patients with acquired immunodeficiency disease
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will not know which group will intervene and what medicine they will receive
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-09-27, 1396/07/05
Ethics committee reference number
Ir.kums.rec.1396.341

Health conditions studied

1

Description of health condition studied
Sepsis
ICD-10 code
A41.9
ICD-10 code description
Sepsis, unspecified

Primary outcomes

1

Description
organ dysfunction
Timepoint
The first day and fourth day study
Method of measurement
Based on laboratory and clinical criteria

2

Description
Length of stay in ICU
Timepoint
28 days after intervention
Method of measurement
Based on patient records

3

Description
Mortality rate
Timepoint
28 days after intervention
Method of measurement
Based on patient records

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will receive 50 mg intravenous ascorbic every 6 hours and up to 6 grams and 200 mg thiamine every 12 hours for 4 days.
Category
Treatment - Drugs

2

Description
The control group will receive 50 mg of placebo for 4 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Alireza Bahrami
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6301
Email
alirezab8188@gmail.Com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, ShahidBeheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
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 Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Bahrami
Position
Residents of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6301
Fax
Email
alirezab8188@gmail.Com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hassanali Karimpour
Position
Specialty of ICU
Latest degree
Subspecialist
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6301
Fax
Email
Hooman.karimpour@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Bahrami
Position
Residents of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6301
Fax
Email
alirezab8188@gmail.Com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
After the end of the study (7 months)
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 7-day period, the documents will be sent e-mail
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