determine the effect of the simultaneous use of vitamin C and E in improving clinical and paraclinical symptoms in patients with lung contusion
Design
A clinical trial with a control group, single blind; non-randomized; Phase 2-3 on 40 patients
Settings and conduct
Patients hospitalized in Shahid Bahonar Hospital will be assigned to one of the exposure or control groups without informing the patients. This process was repeated 24 hours later and 48 hours later. ABG, WBC, ESR before drug administration and 24 and 48 hours after starting the drug and duration of the patient's stay in the ICU and the final outcome (discharge or death) are recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients over 18 years old with lung contusion due to blunt chest trauma based on clinical findings (including respiratory distress, hypoxemia, tachypnea, decreased breath sounds, hypercarbia, subcutaneous emphysema) and radiological or CT scan findings (Focal and non-segmental opacity in lung parenchyma)
Exclusion criteria:
Penetrating trauma or patients intubated for more than 3 days or need of major surgical intervention (including brain, abdominal or major orthopedic surgery such as hip or femur fracture) or Patients with a history of COPD or asthma or GCS less than 13 or Suffering from pulmonary edema, pneumonia or ARDS and Blood exchange
Intervention groups
Exposure group: intravenous infusion of vitamin E (1000 IU in 50 ml of emulsion) and intravenous infusion of vitamin C (500 mg in 50 ml of normal saline) on two occasions with an interval of 24 hours.
Control group: intravenous infusion of distilled water (5 ml in 50 ml of normal saline) on two occasions with an interval of 24 hours.
Main outcome variables
Changes in arterial blood gas analysis (PH, PCO2, PaO2, SPO2)
Length of stay in ICU
Serum levels of inflammatory markers (ESR and WBC)
Final outcome (death, discharge)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240316061302N1
Registration date:2024-09-24, 1403/07/03
Registration timing:prospective
Last update:2024-09-24, 1403/07/03
Update count:0
Registration date
2024-09-24, 1403/07/03
Registrant information
Name
mohammad javad zeinodini meymand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3411 6001
Email address
mj.zeinodini@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of vitamin C and vitamin E co-treatment in improvement of clinical and paraclinical findings of lung contusion patients
Public title
Investigation of vitamin C and vitamin E co-treatment in improvement of clinical and paraclinical findings of lung contusion patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with lung contusion due to blunt trauma to the chest based on clinical findings (including respiratory distress, hypoxemia, tachypnea, decreased breath sounds, hypercarbia, subcutaneous emphysema) and radiological or CT scan findings (focal and non-segmental opacity in the lung parenchyma)
Consent of the patient or the patient's guardian (if the patient is not sufficiently conscious) to participate in the study
Hospitalized in Shahid Bahonar Hospital in 1402-1401
Age above 18 years
Exclusion criteria:
penetrating trauma
Patients under intubation for more than 3 days
Patients requiring major surgical intervention (including brain, abdominal or major orthopedic surgery such as hip or femur fracture)
Patients with a history of COPD or asthma
GCS less than 13
Having pulmonary edema, pneumonia or ARDS
blood exchange
Lack of consent of the patient or the patient's guardian to enter the study
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be blindly assigned to one of the two exposure and control groups based on the opinion of the special care physician and they will not know the type of injectable drug and their group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital - Kerman University of Medical sciences
Street address
Clinical Research Development Unit, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913911
Approval date
2024-09-17, 1403/06/27
Ethics committee reference number
IR.KMU.AH.REC.1403.104
Health conditions studied
1
Description of health condition studied
Lung contusion
ICD-10 code
S27.32
ICD-10 code description
Contusion of lung
Primary outcomes
1
Description
Length of stay in ICU
Timepoint
From the time of admission to the hospital until discharge from the ICU
Method of measurement
Calendar
2
Description
Arterial Blood Gas Analysis
Timepoint
Before drug administration and 24 and 48 hours after drug administration
Method of measurement
ABG measuring laboratory device
3
Description
ESR
Timepoint
Before drug administration and 24 and 48 hours after drug administration
Method of measurement
ESR measuring laboratory device
4
Description
WBC
Timepoint
Before drug administration and 24 and 48 hours after drug administration
Method of measurement
CBC measuring laboratory device
5
Description
Final outcome (death, discharge)
Timepoint
length of hospitalization
Method of measurement
Ducumantation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravenous infusion of vitamin E (1000 IU in 50 ml of emulsion) and intravenous infusion of vitamin C (500 mg in 50 ml of normal saline) on two occasions with an interval of 24 hours.
Category
Treatment - Drugs
2
Description
Control group: Intravenous infusion of distilled water (5 ml in 50 ml of normal saline) on two occasions with an interval of 24 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Firoozeh Abolhasanizadeh
Street address
Gharani Ave
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Fax
+98 34 3132 5830
Email
mj.zeinodini@kmu.ac.ir
Web page address
https://bh.kmu.ac.ir/en
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Research and Technology Office, Samiya Crossroads (Tahmasababad), at the beginning of Ibn Sina Street, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Fax
+98 34 3226 3719
Email
VCR@KMU.AC.IR
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Yes - There is 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
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
The data of the people participating in the study after being deidentified and the results and variables can be fully accessed after 12 months from the publication of the resulting study and the defense of the thesis, subject to the access permission from the ethics committee of Kerman University of Medical Sciences. .
When the data will become available and for how long
The access period starts 12 months after the defense of the thesis
To whom data/document is available
There is no data access limit.
Under which criteria data/document could be used
There is no limit to using the data for the scientific examination of the data.
From where data/document is obtainable
To receive the data, please refer to the scientific officer of the project, Dr. Firozeh Abolhasanizadeh.
What processes are involved for a request to access data/document
After applying and registering the use of data in the research assistant system of Kerman University of Medical Sciences and obtaining the code of ethics, the use of data is unimpeded.