Outcome measurement of pre-hospital prescription of hypertonic sodium in head trauma patients with decreased level of consciusness.
Design
The design of the study is a randomized clinical trial. The randomization method is blocked. Patients will be randomly divided into 2 groups based on 10 blocks. The sample size for each study group is 100.
Settings and conduct
In this study, all patients with head trauma referred to Firoozgar and Haft-e-Tir hospitals with reduced consciousness will be enrolled. Patients will be randomly divided into 2 groups based on 10 blocks. The sample size for each study group is 100. A total of 200 patients will be examined. Patients and data analyzer will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients over 18 years; head trauma patients with decreased level of consciusness. Exclusion criteria: pregnancy; intrusive trauma; burn; the distance between the injury and the ambulance will be more than 30 minutes.
Intervention groups
In intervention group, patients will be injected with 500 cc of hypertonic sodium (50 %) at the site of the accident to the hospital. In control group, patients will be injected with 500 cc of normal saline at the site of the accident to the hospital.
Main outcome variables
Level of consciousness; blood pressure; pressure inside the brain; Oxygen saturation level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151003024317N10
Registration date:2020-01-23, 1398/11/03
Registration timing:prospective
Last update:2020-01-23, 1398/11/03
Update count:0
Registration date
2020-01-23, 1398/11/03
Registrant information
Name
Mahdi Rezai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 6772
Email address
rezaei.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-09, 1398/11/20
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Outcome measurement of pre-hospital prescription of hypertonic sodium in head trauma patients with decreased level of consciusness.
Public title
Measurement of pre-hospital prescription of hypertonic in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old
Head trauma patients with decreased level of consciousness
Exclusion criteria:
Pregnancy
Intrusive Trauma
The distance between the injury and the ambulance will be more than 30 minutes
Burn
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks with 10 person. In each block, 5 individuals will be in intervention group and 5 will be in control group. A total of 20 blocks will be considered for sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Data will be analyzed by person who is blind to study groups. The therapist and patients will also be unaware of the type of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-04-07, 1398/01/18
Ethics committee reference number
IR.IUMS.REC.1398.340
Health conditions studied
1
Description of health condition studied
Head trauma
ICD-10 code
G44.31
ICD-10 code description
Acute post-traumatic headache
Primary outcomes
1
Description
Level of consciousness
Timepoint
At the scene, on arrival at the hospital, after the intervention
Method of measurement
Based on patient records
2
Description
Blood pressure
Timepoint
At the scene, on arrival at the hospital, after the intervention
Method of measurement
Based on patient records
3
Description
Pressure inside the brain
Timepoint
On arrival at the hospital, after the intervention
Method of measurement
Based on patient records
4
Description
Oxygen saturation level
Timepoint
On arrival at the hospital, after the intervention
Method of measurement
Pulse Oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients will be injected with 500 cc of normal saline at the site of the accident to the hospital.
Category
Placebo
2
Description
Intervention group: patients will be injected with 500 cc of hypertonic sodium (50 %) at the site of the accident to the hospital.