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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190311043008N1
Enrollment
100
Registered
2021-02-19
Start date
2020-11-10
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sever Ischemic stroke.

Interventions

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-toni
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 consider

Sponsors

Ghoum University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSharifipour Ehsan

Ghoum University of Medical Sciences

Sharifipour.e @muq.ac.ir+98 25 3612 2000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026