Clinical trial NCT02064075: The Mortality and Changes in Quality of Life of Patients Suffering From SAH With Different Hydration Strategies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subarachnoid Hemorrhage
Keywords: Subarachnoid hemorrhage
vasospasm
Lactated Ringer's solution
Hydroxyethyl starch solution
Lead sponsor: University of Debrecen
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* patients with subarachnoid hemorrhage
* patients with Hunt-Hess grade I-III.

Exclusion Criteria:

* patients with Hunt-Hess grade IV-V.

Primary outcomes:
measure: The incidence of vasospasm
timeFrame: The presence of vasospasm is assessed daily between Day 1 and Day 14 in average (plus or minus 5 days) after SAH has occured
Secondary outcomes:
measure: 30-day survival
timeFrame: 30 days after the incidence of SAH
measure: Glasgow Outcome Scale
timeFrame: 30 days after the incidence of SAH
measure: Barthel Index of Activities of Daily Living
timeFrame: 30 days after the incidence of SAH
measure: National Institutes of Health Stroke Scale
timeFrame: 30 days after the incidence of SAH
Other outcomes:
measure: Noradrenalin need
timeFrame: 30 days after the incidence of SAH
Locations:
city: Debrecen
country: Hungary
facility: University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care
Study officials:
affiliation: University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care 4032-Debrecen, Nagyerdei krt 98. Hungary Tel/fax: +36-52-255-347
name: Csilla Molnár, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gal J, Fulesdi B, Varga D, Fodor B, Varga E, Siro P, Bereczki D, Szabo S, Molnar C. Assessment of two prophylactic fluid strategies in aneurysmal subarachnoid hemorrhage: A randomized trial. J Int Med Res. 2020 Jul;48(7):300060520927526. doi: 10.1177/0300060520927526.