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.
Status | Completed |
Enrollment | 96 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - patients with subarachnoid hemorrhage - patients with Hunt-Hess grade I-III. Exclusion Criteria: - patients with Hunt-Hess grade IV-V. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hungary | University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care | Debrecen |
Lead Sponsor | Collaborator |
---|---|
University of Debrecen |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Noradrenalin need | The overall noradrenalin need during hospital stay. | 30 days after the incidence of SAH | No |
Primary | 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 | No |
Secondary | 30-day survival | 30 days after the incidence of SAH | No | |
Secondary | Glasgow Outcome Scale | 30 days after the incidence of SAH | No | |
Secondary | Barthel Index of Activities of Daily Living | 30 days after the incidence of SAH | No | |
Secondary | National Institutes of Health Stroke Scale | 30 days after the incidence of SAH | No |
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