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Comparison of the effect of hyper-tonic saline with placebo on mortality and three-months hospital prognosis in patients with severe ischemic stroke

Protocol summary

Study aim
Determination of the effect of placebo hyper-tonic saline on mortality and hospital 3-months outcome in patients with severe ischemic stroke
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 100 patients. Patients will be allocated into two groups using apermuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/).
Settings and conduct
The study is performed in Shahid Beheshti Hospital, Department of Neurology,Qom, . In this study, it is a randomized clinical trial in one group will be treated with hypertonic saline and one group will be treated with placebo (normal saline). In the intervention group treated with hyper-tonic saline at a dose of 50 mg every 8 hours with daily sodium checks and osmolarity and its effect on the severity of stroke in the days before treatment, in the same way to patients entering the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1. Moderate to severe ischemic stroke 2- Age between 18 and 80 years 3. No previous use of hypertonic saline and other serums in a recent month before the onset of symptoms Exclusion criteria 1- Having a previous chronic disease that interferes with the functional evaluation of patients, such as cancers, 2-liver or kidney or heart failure, 3 -Chronic infection 4-Dissatisfaction
Intervention groups
The first group receives standard treatment and placebo, which is very similar to our drug, and the second group receives hyper-tonic saline in addition to standard treatment.
Main outcome variables
1.Hospital death 2. Duration of hospitalization 3. interval between hospitalization and discharge 4-Patients recovery in 3 months follow-up

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190311043008N1
Registration date: 2021-02-19, 1399/12/01
Registration timing: registered_while_recruiting

Last update: 2021-02-19, 1399/12/01
Update count: 0
Registration date
2021-02-19, 1399/12/01
Registrant information
Name
Ehsan Sharifipour
Name of organization / entity
Qom university of medical Sciences,Neurosience Research Center
Country
Iran (Islamic Republic of)
Phone
+98 25 3285 2720
Email address
sharifipour.e@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2021-11-10, 1400/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of hyper-tonic saline with placebo on mortality and three-months hospital prognosis in patients with severe ischemic stroke
Public title
The effect of hyper-tonic saline serum on the outcome of patients with severe stroke
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to severe ischemic stroke Age between 18 and 80 years Agreed to participate in the study No previous use of hyper-tonic saline and other serums in the last month before the onset of symptoms Hospitalized in the neurology ward of Shahid Beheshti Hospital,
Exclusion criteria:
Having a previous serious chronic disease that interferes with the functional evaluation of patients, such as cancers, Liver ، kidney ، heart failure, Chronic infection Dissatisfaction
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into two groups using apermuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of specific codes that are obtained by the website.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind: in addition to participants, investigators or the assessors of the outcomes are aslo unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee ofQom University of Medical Sciences
Street address
No. 83, Jahad Daneshgahi Ave., Alghadir Blvd., Deputy of Research
City
Qom
Province
Ghoum
Postal code
3716993456
Approval date
2020-07-21, 1399/04/31
Ethics committee reference number
IR.MUQ.REC.1399.171

Health conditions studied

1

Description of health condition studied
Sever Ischemic stroke
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Death
Timepoint
During Hospitalization
Method of measurement
Physician diagnosis

2

Description
Patient recovery in quarterly follow-up
Timepoint
Before starting treatment on days 5, 10, 30 and three months after starting treatment with hyper-tonic saline
Method of measurement
The initial checklist form includes: type of stroke, frequency of stroke, risk factors and clinical scoring score based on the National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (MRS).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients who receive packages including standard treatments plus hypertonic saline serum made by Shahid Ghazi Company. Initial dose of 200 ml of serum 5% hyper-tonic saline then 50 ml every hour for up to seven days. Provided that sodium ; Less than 155 mg / l, and blood osmolality less than 320 mg / dL.
Category
Other

2

Description
Control group: Patients who receive a package containing standard treatments plus normal saline serum will be considered group 1. The package containing standard treatments plus normal saline serum will receive 200 ml, then 50 ml every hour for up to seven days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Ehsan Sharifipour
Street address
Shahid Chamran Ave.,
City
QOM
Province
Ghoum
Postal code
3719964797
Phone
+98 21 3612 2000
Email
Sharifipour.e@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Sharifipour Ehsan
Street address
Shahid Beheshti Ave
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
Sharifipour.e@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Sharifipour Ehsan
Position
Assistant Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Shahid Beheshti Ave
City
Qom
Province
Ghoum
Postal code
3719644797
Phone
+98 25 3612 2000
Email
Sharifipour.e @muq.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ehsan Sharifipour
Position
Assistant Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Shahid Beheshti Ave.,Chamran Blvd., Neuroscience Research Center
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 2720
Email
Sharifipour.e@muq.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr Ehsan Sharifipour
Position
Assistant Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Shahid Beheshti Blvd
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 2720
Email
Sharifipour.e@muq.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Information on the main outcome is available
When the data will become available and for how long
Access period starts 6 months after the results are published.
To whom data/document is available
Will be allowed for neurologists from medical universities.
Under which criteria data/document could be used
Collaborators at other medical universities will be allowed to comment on the consequences of the results.
From where data/document is obtainable
Contact the main executor of the project in Qom University of Medical Sciences by email.
What processes are involved for a request to access data/document
The applicant must be a partner in the project and in contact with the executor. After reviewing the application, the executor will send it by email within a week.
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