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More progressive stroke in one arm
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| Name | Class |
|---|---|
| National Research Council of Thailand | OTHER_GOV |
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To study the result of intravenous fluid in patients with acute ischemic stroke within 72 hours.
This study aims to find the effect of early IV fluid administration to patients with acute ischemic stroke on the neurological outcome and to determine the side effects of intravenous fluids. Due to its cost effectiveness and wide accessibility, the possible application or use of IV fluid infusion as first line treatment can aide in the treatment of more acute ischemic stroke patients worldwide. This novel information will aide physicians with more comprehensive understanding of the efficacy of utilizing IV fluid in future treatment plans for patients with acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Fluid | Experimental | 0.9% NaCl solution infusion: 100 ml/hr for three days. |
|
| No IV Fluid | No Intervention | Not receive any intravenous fluid but can consume oral fluid normally for three days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% NaCl solution | Drug | 0.9% NaCl solution intravenous infusion: 100 ml/hr for three days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS ≤ 4 | Patients with good outcome by NIHSS ≤ 4 at day 7 after treatment or on the day of discharge, which ever comes first. | day 7 after treatment or on the day of discharge |
| Measure | Description | Time Frame |
|---|---|---|
| mRS ≤ 1 | Patients with mRS ≤ 1 at day 7 after treatment or on the day of discharge, which ever comes first. | day 7 after treatment or on the day of discharge |
| mRS ≤ 4 | Patients with mRS ≤ 4 at day 90 |
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Inclusion Criteria:
Exclusion Criteria:
Patients receiving > 40 ml/hr IV fluid infusion over 3 hours
Acute ischemic stroke caused cardiogenic embolism
Urine specific gravity ≥ 1.030
Large cerebral infarction area
NHISS ≥ 18
Previous or current episode of atrial fibrillation
Previous or current episode congestive heart failure
Previous echocardiogram with ejection fraction < 40%
Previous or current episode of dilated cardiomyopathy
Abnormal renal function GFR ≤ 60% or serum creatinine ≥ 2
Modified Rankin scale before acute ischemic stroke ≥ 2
Patients receiving intravenous thrombolysis
NPO with need for IV fluid
IV fluid infusion needed from any other causes
Patients with poor prognosis with life expectancy < 90 days
Patients involved in other ongoing clinical studies
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| Name | Affiliation | Role |
|---|---|---|
| Nijasri C Suwanwela, MD | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn University | Bangkok | Bangkok | 10330 | Thailand |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| at day 90 |
| mRS ≤ 1 | Patients with mRS ≤ 1 at day 90 | at day 90 |
| change of serum osmolarity | Percentage of change of serum osmolarity at day 3 after treatment | at day 3 after treatment |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |