Protocol summary

Study aim
To evaluate the effect of magnesium sulfate on hemodynamic and respiratory parameters of multiple trauma patients under mechanical ventilation
Design
Phase III single-blind (assessor-blind) randomized controlled trial with parallel groups on 104 patients, randomization performed using a randomization table generated by the Random Allocation software
Settings and conduct
This study will include 104 multiple trauma patients under mechanical ventilation in Shahid Mohammadi Hospital intensive care unit, Bandar Abbas. Patients will be randomized into two groups. Patients in the intervention group will receive 2 g magnesium sulfate 20% in daily serum within the first 24 hours and those in the control group will only receive daily serum. Blood pressure, heart rate, oxygen saturation, pulmonary compliance, and airway resistance will be assessed every 6 hours and arterial blood gas every 12 hours by an individual blinded to the patient grouping (assessor-blind). Mechanical ventilation will be under volume control mode with 6 L tidal volume, 10-14/min respiratory rate, 40-50% fraction of inspired oxygen, positive end-respiratory pressure of 5, and pressure support of 10. Also, all patients will receive 50-100 mcg/h fentanyl and 1-2 mg/h midazolam.
Participants/Inclusion and exclusion criteria
Inclusion criteria: multiple trauma, mechanical ventilation, admission to the intensive care unit within 24 hours of trauma, age 18-70 years Exclusion criteria: history of pulmonary disease such as asthma and chronic obstructive pulmonary disease, pulmonary contusion, pneumothorax, cardiovascular instability
Intervention groups
Intervention group: 2 g magnesium sulfate 20% in daily serum within the first 24 hours Control group: Only daily serum within the first 24 hours
Main outcome variables
Blood pressure, oxygen saturation (SpO2), heart rate, pulmonary compliance, airway resistance, arterial blood gas

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230719058853N1
Registration date: 2023-08-12, 1402/05/21
Registration timing: prospective

Last update: 2023-08-12, 1402/05/21
Update count: 0
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
Sarina Charani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 7000
Email address
sarinach9678@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of magnesium sulfate on hemodynamic and respiratory parameters of multiple trauma patients under mechanical ventilation
Public title
The effect of magnesium sulfate on the heart and respiration of multiple trauma patients under mechanical ventilation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Multiple trauma Mechanical ventilation Admission to the intensive care unit within 24 hours of trauma Age 18-70 years
Exclusion criteria:
History of pulmonary diseases such as asthma and chronic obstructive pulmonary disease Pulmonary contusion Pneumothorax Cardiovascular instability
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized into two groups using simple randomization with individuals as the unit of randomization and a randomization table produced by the Random Allocation software. An individual uninvolved in the study will write A or B on a card and put it in an opaque envelope. Then the associated number in the randomization table will be written on the back of the envelope. One envelope will be allocated to each patient in order of entrance to the study. Allocation concealment will be done using opaque envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
The individual responsible for the assessment of hemodynamic and respiratory parameters will be unaware of patient grouping, while given the nature of the intervention and that there is no placebo, the patient and those related to the patient will not be blinded. Therefore, the study will be single-blind with blinding the assessor.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Faculty of Medicine, Across from Kargaran Sports Complex, Imam Hossein Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2023-07-30, 1402/05/08
Ethics committee reference number
IR.HUMS.REC.1402.211

Health conditions studied

1

Description of health condition studied
Multiple trauma
ICD-10 code
T07
ICD-10 code description
Unspecified multiple injuries

Primary outcomes

1

Description
Blood pressure
Timepoint
Every 6 hours within the first 24 hours
Method of measurement
The monitoring device of the intensive care unit

2

Description
Oxygen saturation
Timepoint
Every 6 hours within the first 24 hours
Method of measurement
Pulse oximeter

Secondary outcomes

1

Description
Heart rate
Timepoint
Every 6 hours within the first 24 hours
Method of measurement
The monitoring device of the intensive care unit

2

Description
Pulmonary compliance
Timepoint
Every 6 hours within the first 24 hours
Method of measurement
The ventilator device

3

Description
Airway resistance
Timepoint
Every 6 hours within the first 24 hours
Method of measurement
The ventilator device

4

Description
Arterial blood gas
Timepoint
Every 12 hours within the first 24 hours
Method of measurement
Arterial blood gas measurement in arterial blood sample

Intervention groups

1

Description
Intervention group: 2 g magnesium sulfate 20% (Shahid Ghazi Co., Tabriz, Iran) in daily serum within 24 hours
Category
Prevention

2

Description
Control group: Only daily serum within the first 24 hours
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Sarina Charani
Street address
Shahid Mohammadi Hospital, Jomhouri Eslami Blvd., Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 7000
Email
shmh@hums.ac.ir
Web page address
https://shmh.hums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellery for Research Hormozgan University of Medical Sciences
Full name of responsible person
Teamur Aghamolaei
Street address
Faculty of Medicine, Across from Kargaran Sports Complex, Imam Hossein Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0393
Email
teaghamolaei@gmail.com
Web page address
https://resv.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery for Research Hormozgan 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sarina Charani
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi Hospital, Jomhuri Eslami Blvd., Bandar Abbas, Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 7000
Fax
Email
sarinach9678@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sarina Charani
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi Hospital, Jomhuri Eslami Blvd., Bandar Abbas, Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 7000
Fax
Email
sarinach9678@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sarina Charani
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi Hospital, Jomhuri Eslami Blvd., Bandar Abbas, Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 7000
Fax
Email
sarinach9678@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...