The Mortality and Changes in Quality of Life of Patients Suffering From SAH With Different Hydration Strategies
Λέξεις-κλειδιά
Αφηρημένη
Περιγραφή
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.
Ημερομηνίες
| Τελευταία επαλήθευση: | 01/31/2014 |
| Πρώτα υποβλήθηκε: | 02/08/2014 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 02/12/2014 |
| Δημοσιεύτηκε για πρώτη φορά: | 02/16/2014 |
| Υποβλήθηκε τελευταία ενημέρωση: | 02/12/2014 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 02/16/2014 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 01/31/2013 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 09/30/2013 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 09/30/2013 |
Κατάσταση ή ασθένεια
Παρέμβαση / θεραπεία
Drug: Lactated Ringer's solution
Drug: Hydroxyethyl starch
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| Active Comparator: Hydroxyethyl starch 15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day. | Drug: Hydroxyethyl starch 15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day until discharge. |
| Active Comparator: Lactated Ringer's solution 15-50 ml/kg Lactated-Ringer's solution was given intravenously every day. | Drug: Lactated Ringer's solution 15-50 ml/kg Lactated-Ringer's solution was given intravenously every day until discharge. |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 18 Years Προς την 18 Years |
| Φύλα επιλέξιμα για μελέτη | All |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | Inclusion Criteria: - patients with subarachnoid hemorrhage - patients with Hunt-Hess grade I-III. Exclusion Criteria: - patients with Hunt-Hess grade IV-V. |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. The incidence of vasospasm [The presence of vasospasm is assessed daily between Day 1 and Day 14 in average (plus or minus 5 days) after SAH has occured]
Δευτερεύοντα αποτελέσματα
1. 30-day survival [30 days after the incidence of SAH]
2. Glasgow Outcome Scale [30 days after the incidence of SAH]
3. Barthel Index of Activities of Daily Living [30 days after the incidence of SAH]
4. National Institutes of Health Stroke Scale [30 days after the incidence of SAH]
Άλλα μέτρα αποτελεσμάτων
1. Noradrenalin need [30 days after the incidence of SAH]
