Czech
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

The Mortality and Changes in Quality of Life of Patients Suffering From SAH With Different Hydration Strategies

Články mohou překládat pouze registrovaní uživatelé
Přihlášení Registrace
Odkaz je uložen do schránky
PostaveníDokončeno
Sponzoři
University of Debrecen

Klíčová slova

Abstraktní

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.

Popis

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.

Termíny

Poslední ověření: 01/31/2014
První předloženo: 02/08/2014
Odhadovaná registrace vložena: 02/12/2014
První zveřejnění: 02/16/2014
Poslední aktualizace byla odeslána: 02/12/2014
Poslední aktualizace zveřejněna: 02/16/2014
Aktuální datum zahájení studie: 01/31/2013
Odhadované datum dokončení primární: 09/30/2013
Odhadované datum dokončení studie: 09/30/2013

Stav nebo nemoc

Subarachnoid Hemorrhage

Intervence / léčba

Drug: Lactated Ringer's solution

Drug: Hydroxyethyl starch

Fáze

Fáze 4

Skupiny zbraní

PažeIntervence / léčba
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.

Kritéria způsobilosti

Věky způsobilé ke studiu 18 Years Na 18 Years
Pohlaví způsobilá ke studiuAll
Přijímá zdravé dobrovolníkyAno
Kritéria

Inclusion Criteria:

- patients with subarachnoid hemorrhage

- patients with Hunt-Hess grade I-III.

Exclusion Criteria:

- patients with Hunt-Hess grade IV-V.

Výsledek

Primární výsledná opatření

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]

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)

Měření sekundárních výsledků

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]

Další výsledková opatření

1. Noradrenalin need [30 days after the incidence of SAH]

The overall noradrenalin need during hospital stay.

Připojte se k naší
facebookové stránce

Nejúplnější databáze léčivých bylin podložená vědou

  • Funguje v 55 jazycích
  • Bylinné léky podporované vědou
  • Rozpoznávání bylin podle obrázku
  • Interaktivní mapa GPS - označte byliny na místě (již brzy)
  • Přečtěte si vědecké publikace související s vaším hledáním
  • Hledejte léčivé byliny podle jejich účinků
  • Uspořádejte své zájmy a držte krok s novinkami, klinickými testy a patenty

Zadejte symptom nebo chorobu a přečtěte si o bylinách, které by vám mohly pomoci, napište bylinu a podívejte se na nemoci a příznaky, proti kterým se používá.
* Všechny informace vycházejí z publikovaného vědeckého výzkumu

Google Play badgeApp Store badge