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| ID | Type | Description | Link |
|---|---|---|---|
| DEOEC RKEB/IKEB:3799-2012 | Other Identifier | University of Debrecen,RKEB/IKEB |
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Purpose:
- Vasospasm and secondary ischemia following subarachnoidal hemorrhage considerably affect the clinical outcome. The purpose of this study is to determine whether crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch) intravenous infusion is more effective in the treatment of subarachnoid hemorrhage (SAH)
Treatment:
- Patients are randomly divided into two groups. Depending on the blood pressure of the patients the members of the first group receive 15-50 ml/kg Lactated-Ringer's solution daily as part of the treatment, while the others 15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution daily.
Measurements:
Hypothesis:
-The prevalence of vasospasms, the mortality rate and the medium-term quality of life following subarachnoid hemorrhage is improved if patients are treated with intravenous colloid (hydroxyethyl starch) infusion compared to intravenous crystalloid infusion.
Study protocol:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxyethyl starch | Active Comparator | 15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day. |
|
| Lactated Ringer's solution | Active Comparator | 15-50 ml/kg Lactated-Ringer's solution was given intravenously every day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactated Ringer's solution | Drug | 15-50 ml/kg Lactated-Ringer's solution was given intravenously every day until discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of vasospasm | The presence of vasospasm is assessed with the help of a transcranial doppler device. Vasospasm is diagnosed if the mean blood flow velocity in the middle cerebral artery is higher than 120 cm/s (centimeter/second) | The presence of vasospasm is assessed daily between Day 1 and Day 14 in average (plus or minus 5 days) after SAH has occured |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day survival | 30 days after the incidence of SAH | |
| Glasgow Outcome Scale | 30 days after the incidence of SAH | |
| Barthel Index of Activities of Daily Living |
| Measure | Description | Time Frame |
|---|---|---|
| Noradrenalin need | The overall noradrenalin need during hospital stay. | 30 days after the incidence of SAH |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Csilla Molnár, Md, PhD | University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care 4032-Debrecen, Nagyerdei krt 98. Hungary Tel/fax: +36-52-255-347 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care | Debrecen | 4032 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32689849 | Derived | Gal J, Fulesdi B, Varga D, Fodor B, Varga E, Siro P, Bereczki D, Szabo S, Molnar C. Assessment of two prophylactic fluid strategies in aneurysmal subarachnoid hemorrhage: A randomized trial. J Int Med Res. 2020 Jul;48(7):300060520927526. doi: 10.1177/0300060520927526. |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| D006895 | Hydroxyethyl Starch Derivatives |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Hydroxyethyl starch | Drug | 15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day until discharge. |
|
|
| 30 days after the incidence of SAH |
| National Institutes of Health Stroke Scale | 30 days after the incidence of SAH |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013213 |
| Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
| D011134 | Polysaccharides |