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NCT Number: NCT02064075

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

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.

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Key information

Conditions

Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care

Debrecen, 4032, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients with Hunt-Hess grade IV-V.

Treatment and study plan

Lactated Ringer's solution

Drug

15-50 ml/kg Lactated-Ringer's solution was given intravenously every day until discharge.

Hydroxyethyl starch

Drug

15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day until discharge.

Other names: HES 130/0.4

Primary outcomes

  1. The incidence of vasospasm

    Time frame: 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)

Secondary outcomes

  1. 30-day survival

    Time frame: 30 days after the incidence of SAH

  2. Glasgow Outcome Scale

    Time frame: 30 days after the incidence of SAH

  3. Barthel Index of Activities of Daily Living

    Time frame: 30 days after the incidence of SAH

  4. National Institutes of Health Stroke Scale

    Time frame: 30 days after the incidence of SAH

Other outcomes

  1. Noradrenalin need

    Time frame: 30 days after the incidence of SAH

    The overall noradrenalin need during hospital stay.

Sponsors and collaborators

Lead sponsor

University of Debrecen

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 17, 2014
Registry last updated
Feb 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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