The Mortality and Changes in Quality of Life of Patients Suffering From SAH With Different Hydration Strategies
Condition: Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Lactated Ringer's solution; Hydroxyethyl starch
Intervention type(s): Drug; Drug
Intervention description(s): 15-50 ml/kg Lactated-Ringer's solution was given intravenously every day until discharge.; 15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day until discharge.
Other intervention name(s): HES 130/0.4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Subarachnoid hemorrhage; vasospasm; Lactated Ringer's solution; Hydroxyethyl starch solution