In this study, on patients with severe pneumonia admitted to the intensive care unit, the effect of prescription vitamin C on the mortality rate of patients will be examined.
Design
A simple randomized, double-blind, placebo-controlled clinical trial
Settings and conduct
In a double-blind clinical trial, 80 patients admitted to the ICU for severe pneumonia were determined according to the relevant criteria and enrolled randomly into two groups of 40 patients receiving standard and routine treatments and group receiving standard and routine treatments in addition to vitamin C .The study will be conducted at Sina Hospital in Tabriz and patients, clinical caregivers, and data analysts will be unaware of grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients with severe pneumonia based on the criteria and exclusion criteria included patients who were unable to survive more than 24 hours due to end stage co-morbidities or clinical deterioration. Patients who consumed up to 48 hours prior to admission to unknown doses of vitamin C, patients who had a history of warfarin medication 24 hours prior to the study, with or without their consent, or their peers, or patients who did not receive informed consent from the patient or family. serum creatinine is above 1.5, patients below 18 and above For 90 years, patients with G6PD deficiency, patients with bleeding disorders, and patients with a history of renal oxalate stones will be excluded.
Intervention groups
Intervention group:Group who receive standard and routine treatment of pneumonia in addition to vitamin C (50mg/kg/day)
Control group:Group who receive standard and routine treatment of pneumonia in addition to the same volume of normal saline
Main outcome variables
Mortality ؛ Mechanical ventilation free days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190312043030N1
Registration date:2019-08-26, 1398/06/04
Registration timing:registered_while_recruiting
Last update:2019-08-26, 1398/06/04
Update count:0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
seied hadi saghaleini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1994
Email address
saghaleinih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-15, 1398/02/25
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Vitamin C administration in patients mortality with severe pneumonia in ICU
Public title
Effect of Vit C in severe pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who have been diagnosed with severe pneumonia criteria
Exclusion criteria:
Patients who are not able to survive for more than 24 hours because of end-stage or clinical deterioration
Patients with their own dissatisfaction or the inability to obtain informed consent from the patient or family of patients
Patients under the age of 18 and over
Patients who have had warfarin use 24 hours before study
Patients who received up to 48 hours prior to admission Undetermined vitamin C
Patients with bleeding disorders
Patients with G6PD deficiency
Patients with primary creatinine above 1.5
Patients with a history of kidney oxalate stones
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
We will construct 6 blocks in AABB, BBAA, ABAB, BABA, ABBA and BAAB using four blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 20 units of 4 blocks will be selected so that we consider having 40 people in control group (A) and 40 people in intervention group (B). Therefore, we will do block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients, clinical caregivers, and data analyzers will not aware of grouping .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Science, Gholghasht street, Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2019-07-30, 1398/05/08
Ethics committee reference number
IR.TBZMED.REC.1398.482
Health conditions studied
1
Description of health condition studied
Effects of vitamin C administration in patients mortality with severe pneumonia in ICU
ICD-10 code
A40.3
ICD-10 code description
Sepsis due to Streptococcus pneumoniae
Primary outcomes
1
Description
Frequency of mortality
Timepoint
28 days mortality rate
Method of measurement
Sequential organ failure Assessment score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The recipient group will receive standard and routine pneumonia treatments including respiratory support and serum therapy and mechanical ventilation, empirical antibiotic therapy and subsequent antibiotic therapy with appropriate dose based on the results of cultures and relevant antibiograms, respectively, for 14 days. Appropriate doses of bronchodilator (salbutamol) and inhaled anticholinergic (Ipratropium bromide) mucolytic therapy (ampoule n-acetylcysteine) will also be used to treat these patients in addition to vitamin C (50mg / kg). The prescribed dose of Vitamin C 50mg / kg / day will be divided into 4 equal doses, each administered at 6 hours interval for 30 minutes at 50 ml DW5 serum (which will be included in the patient's serum intake) will continue for 4 days
Category
Treatment - Drugs
2
Description
Control group:Group who will receive standard and routine pneumonia treatments including respiratory support and serum therapy and mechanical ventilation, emprical antibiotic therapy and subsequent antibiotic therapy with appropriate dose based on the results of cultures and relevant antibiograms, respectively, for 14 days. Appropriate doses of bronchodilator (salbutamol) and inhaled anticholinergic (Ipratropium bromide) mucolytic therapy (ampoule n-acetylcysteine) will also be used to treat these patients in addition to the same volume of normal saline in intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr.Seied Hadi Saghaleini
Street address
East Azerbaijan Province, Tabriz, North West Medical Toxicology Center ,Sina hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Fax
+98 41 3541 2101
Email
hsaghaleini@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Joyban
Street address
Vice chancellor for research, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Fax
+98 41 3335 7310
Email
hsaghaleini@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Seyed Hadi Saghaleini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
East Azerbaijan Province, Tabriz, North West Medical Toxicology Center,Sina Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Fax
+98 41 3541 2101
Email
hsaghaleini@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Seyed Hadi Saghaleini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
East Azerbaijan Province, Tabriz, North West Medical Toxicology Center,Sina Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Fax
+98 41 3541 2101
Email
hsaghaleini@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Seyed Hadi Saghaleini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
East Azerbaijan Province, Tabriz, North West Medical Toxicology Center,Sina Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Fax
+98 41 3541 2101
Email
hsaghaleini@gmail.com
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
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
all collected deidentified IPD, IPD collected for the primary outcome measure are to be shared
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
documents will be available for people working in academic institutions and also people working in businesses.
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data.
From where data/document is obtainable
Dr .Seyed Hadi Saghaleini Sina Hospital Azadi Street, Sina Hospital, Tabriz East Azarbaijan Islamic Republic of Iran Phone+98 41 35412101 Fax+98 41 35412101 hsaghaleini@gmail.com
What processes are involved for a request to access data/document