Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02064075
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : February 17, 2014
Sponsor:
Information provided by (Responsible Party):
Tamas Vegh, MD, University of Debrecen

Tracking Information
First Submitted Date  ICMJE February 9, 2014
First Posted Date  ICMJE February 17, 2014
Last Update Posted Date February 17, 2014
Study Start Date  ICMJE February 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2014)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2014)
  • 30-day survival [ Time Frame: 30 days after the incidence of SAH ]
  • Glasgow Outcome Scale [ Time Frame: 30 days after the incidence of SAH ]
  • Barthel Index of Activities of Daily Living [ Time Frame: 30 days after the incidence of SAH ]
  • National Institutes of Health Stroke Scale [ Time Frame: 30 days after the incidence of SAH ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 13, 2014)
Noradrenalin need [ Time Frame: 30 days after the incidence of SAH ]
The overall noradrenalin need during hospital stay.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Mortality and Changes in Quality of Life of Patients Suffering From SAH With Different Hydration Strategies
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Subarachnoid Hemorrhage
Intervention  ICMJE
  • Drug: Lactated Ringer's solution
    15-50 ml/kg Lactated-Ringer's solution was given intravenously every day until discharge.
  • Drug: Hydroxyethyl starch
    15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day until discharge.
    Other Name: HES 130/0.4
Study Arms  ICMJE
  • Active Comparator: Hydroxyethyl starch
    15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day.
    Intervention: Drug: Hydroxyethyl starch
  • Active Comparator: Lactated Ringer's solution
    15-50 ml/kg Lactated-Ringer's solution was given intravenously every day.
    Intervention: Drug: Lactated Ringer's solution
Publications * Gál J, Fülesdi B, Varga D, Fodor B, Varga E, Siró P, Bereczki D, Szabó S, Molnár 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2014)
96
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with Hunt-Hess grade IV-V.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02064075
Other Study ID Numbers  ICMJE 6163-1/2013/EKU
DEOEC RKEB/IKEB:3799-2012 ( Other Identifier: University of Debrecen,RKEB/IKEB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tamas Vegh, MD, University of Debrecen
Study Sponsor  ICMJE University of Debrecen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Csilla Molnár, Md, PhD 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
PRS Account University of Debrecen
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP