Subarachnoid Hemorrhage Clinical Trial
Official title:
Phase 4 Prospective, Randomized, Blinded Study on the Effect of Different Hydration Strategies on Mortality and Changes in Quality of Life of Patients Suffering From Subarachnoid Haemorrhage
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:
- Neurological status of patients will be determined by the NIH Stoke Scale Score and the
Glasgow Coma Scale (GCS) on a daily basis.
- The mid-term survival and quality of life are evaluated with Barthel Index and Glasgow
Outcome Scale (GOS) 14 and 30 days following admission to our clinic.
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:
- Upon arrival Computed Tomography Angiography (CTA), or if necessary, a four-vessel
cerebral angiography is carried out in case of each patient. Previous medical history
is obtained with particular regard to the onset of the symptoms and the premorbid blood
pressure values. Afterwards the Hunt-Hess classification of the patients take place.
The neurological condition is recorded with the help of the NIH Stroke Scale on a daily
basis. An acute or delayed open surgery or endovascular coiling is carried out by
either a neurosurgeon or an interventional neuroradiologist as the definitive treatment
of the aneurysm.
- Patients are randomized into two groups, either treated with Lactated Ringer's or
hydroxyethyl starch solutions. Patients of the Lactated Ringer's are given 15-50
ml/kg/day Lactated Ringer's infusion from the beginning of their enrollment, while
members of the other group receive 15 ml/kg Lactated-Ringer's and 15-50 ml/kg
hydroxyethyl starch solution daily. The blood pressure should not exceed the 160 mmHg
systolic and 110 mm Hg mean value prior to the definitive treatment. After definitive
care the target blood pressure is set to ensure a clinically optimal state, which
should not above 150% of the premorbid blood pressure, and should not exceed 200/120
mmHg. In order to achieve and maintain these values additional vasoactive drugs
(arterenol, dobutrex) could be administered regardless of the group in a maximum dose
of 2.5 micrograms/kg/min arterenol, with an additional dose of 10 ug/kg/min dobutrex if
necessary, if the sole intake of intravenous solutions are not sufficient. Blood
pressure is measured invasively, continuously after the cannulation of the radial
artery.
- Neurological status of patients will be determined by the NIH Stoke Scale Score and the
Glasgow Coma Scale (GCS) on a daily basis. The mid-term survival and quality of life
are evaluated with Barthel Index and Glasgow Outcome Scale (GOS) 14 and 30 days
following admission to our clinic.
- The primary outcome measure of the study is the incidence rate of vasospasm in both
groups, while secondary outcome measures included 30-day survival, the neurological
status and GOS scores after.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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