]>
IRCT20190311043008N1 IRCT 2021-02-19 Ghoum University of Medical Sciences The effect of hyper-tonic saline serum on the outcome of patients with severe stroke Comparison of the effect of hyper-tonic saline with placebo on mortality and three-months hospital prognosis in patients with severe ischemic stroke 2020-11-10 anticipated 100 Complete https://irct.ir/trial/52018 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, 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 description: Double blind: in addition to participants, investigators or the assessors of the outcomes are aslo unaware of the study groups. 3 Sever Ischemic stroke. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Information on the main outcome is available When: Access period starts 6 months after the results are published. To whom: Will be allowed for neurologists from medical universities. Conditions: Collaborators at other medical universities will be allowed to comment on the consequences of the results. Where to obtain: Contact the main executor of the project in Qom University of Medical Sciences by email. How to obtain: 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. Comments:
public Sharifipour Ehsan
Shahid Beheshti Ave
Qom Iran (Islamic Republic of) 3719644797 +98 25 3612 2000 Sharifipour.e @muq.ac.ir Ghoum University of Medical Sciences scientific Ehsan Sharifipour
Shahid Beheshti Ave.,Chamran Blvd., Neuroscience Research Center
Qom Iran (Islamic Republic of) 3716993456 +98 25 3285 2720 Sharifipour.e@muq.ac.ir Ghoum University of Medical Sciences Iran (Islamic Republic of) 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, 18 years 80 years Both Having a previous serious chronic disease that interferes with the functional evaluation of patients, such as cancers, Liver ، kidney ، heart failure, Chronic infection Dissatisfaction Other Placebo 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. 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. Death. Timepoint: During Hospitalization. Method of measurement: Physician diagnosis. 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). Ghoum University of Medical Sciences Approved 2020-07-21 Ethics committee ofQom University of Medical Sciences No. 83, Jahad Daneshgahi Ave., Alghadir Blvd., Deputy of Research Qom Ghoum Iran (Islamic Republic of)