Effect of High Doses of Vitamin C on Coagulation Factors and Vascular endothelium in Sepsis Patients
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 50 patients. Block Randomization was used for randomization.
Settings and conduct
This RCT study will be conducted in the special care units of Sinai Hospital in 2018-2019. Adult patients with sepsis who are hospitalized in the intensive care unit and meet the inclusion criteria, after obtaining the form
Consent will be included in the study. Patients will be randomly divided into two groups of 25 people - 1:1 through Block Randomization.
• The first group, in addition to the standard treatment, 25 mg/kg of vitamin C as a bolus every six hours for 72 hours.
will receive and
• The second group will receive only the standard treatment.
a sample is taken from them and checked in the laboratory
Participants/Inclusion and exclusion criteria
Entry requirements:
Having sepsis according to the criteria stated in the Surviving Sepsis Campaign 2016 Guideline based on SOFAScore
Non-entry conditions:
Age less than 18 years
• Age above 80 years
• pregnancy
• kidney failure: AKI according to the definition of KDIGO guidelines
• Receiving other antioxidants 24 hours before and during the study (NAC, melatonin and selenium)
• Receiving intravenous fibrinogen
• Receive intravenous PCC
• Receiving heparin with a therapeutic dose
INR˃1.5 •
(PLT˂100000) Thrombocytopenia
• Patients receiving warfarin
• Hemochromatosis patients
Chronic renal failure (GFR<40)
• More than 48 hours have passed since the onset of sepsis
Intervention groups
In addition to the standard treatment, the first group will receive 25 mg/kg of vitamin C as a bolus every six hours for 72 hours.
The second group will receive only the standard treatment.
Investigating the effect of high doses of intravenous vitamin C on coagulation factors and vascular endothelium in sepsis patients
Public title
Effect of High Doses of intravenous Vitamin C on Coagulation Factors and Vascular endothelium in Sepsis Patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having sepsis according to the criteria stated in the surviving sepsis campaign 2016 Guideline based on SOFAScore
Exclusion criteria:
Age less than 18 years
Age above 80 years
pregnancy
Suffering from kidney failure: AKI according to the definition of KDIGO guidelines
Receiving other antioxidants 24 hours before and during the study (NAC, melatonin and selenium)
Receive intravenous fibrinogen
Receive intravenous PCC
Receiving heparin with a therapeutic dose
INR˃1.5
(PLT˂100000 ) Thrombocytopenia
Patients receiving warfarin
Hemochromatosis patients
Chronic renal failure (GFR˂40)
More than 48 hours have passed since the onset of sepsis
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be recorded on an Excel file by the principal investigator. Participants will be randomized via permuted block randomization. Each block will be consistent of variable sizes of 4 or 6 or 8 patients. For assignment of each patient to the drug or control group, for each patients a unique code consistent of 2 letters and a digit will be assigned. the code will be unique for each patient ( for example code AB1 for first patient). Only the principle investigator will be informed of the assignment of each code to the medication or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are included in the study after obtaining consent, but patients are blinded to whether they receive only the treatment of Titarard or receive it along with the standard treatment of vitamin C.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Vice-Chancellor in Research Affairs- Tehran University of Medical Scien
Street address
Keshavarz Blvd., intersection of Quds St., University of Medical Sciences Central Building, 6th floor, room 604
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-04-06, 1399/01/18
Ethics committee reference number
IR.TUMS.VCR.REC.1399.158
Health conditions studied
1
Description of health condition studied
Covid 19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Antithromobin III
Timepoint
From the beginning to the end of the course
Method of measurement
elisa kit
2
Description
Neutrophil to lymphocyte ratio
Timepoint
From the beginning to the end of the course
Method of measurement
Counting blood cells (CBC diff).
3
Description
syndecan-1
Timepoint
From the beginning to the end of the course
Method of measurement
Kit
4
Description
Mortality
Timepoint
From the beginning to the end of the course
Method of measurement
observation
5
Description
Vasopressor dose
Timepoint
From the beginning to the end of the course
Method of measurement
observation
6
Description
CRP/ALB ratio
Timepoint
From the beginning to the end of the course
Method of measurement
Laboratory
7
Description
ACR
Timepoint
From the beginning to the end of the course
Method of measurement
Laboratory
8
Description
FDP/D-Dimer Ratio
Timepoint
From the beginning to the end of the course
Method of measurement
Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Control group: They will receive only standard treatment.
Category
Treatment - Drugs
2
Description
Intervention group: In addition to standard treatment (antibiotics, fluid therapy, etc.), they will receive 25 mg/kg of vitamin C (Vial of injectable vitamin C 500mg/5ml, Alborz Daro) as a bolus every six hours for 72 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Kiumarth Amini
Street address
Imam Khomeini St, Hasan Abad Square
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
hosp_sina@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Medical Sciences in Tehran
Street address
13th Floor, Block A, Ministry of Health, Medical Education, Simai Street, between South Flamak and Zarafshan, Quds town, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 912 519 7344
Email
drkiumarthamini1364@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Kiumarth Amini
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Number 76, Niloufar alley, Abidar st
City
Sanandaj
Province
Kurdistan
Postal code
6618654561
Phone
09808732238602
Email
drkiumarthamini1364@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kiumarth Amini
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Number 76, Niloufar alley, Abidar st
City
Sanandaj
Province
Kurdistan
Postal code
6618654561
Phone
09808732238602
Email
drkiumarthamini1364@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kiumarth Amini
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Number 76, Niloufar alley, Abidar st
City
Sanandaj
Province
Kurdistan
Postal code
6618654561
Phone
09808732238602
Email
drkiumarthamini1364@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
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
All data can be shared.
When the data will become available and for how long
The access period starts six months after the publication of the article.
To whom data/document is available
All researchers
Under which criteria data/document could be used
for research purposes.
From where data/document is obtainable
In the uploaded databases, the link will be provided to the applicants.
What processes are involved for a request to access data/document
Check the requester's information and then send the link.