The Mortality and Changes in Quality of Life of Patients Suffering From SAH With Different Hydration Strategies
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
2 other identifiers
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 9, 2014
CompletedFirst Posted
Study publicly available on registry
February 17, 2014
CompletedFebruary 17, 2014
February 1, 2014
8 months
February 9, 2014
February 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of vasospasm
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)
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 (4)
30-day survival
30 days after the incidence of SAH
Glasgow Outcome Scale
30 days after the incidence of SAH
Barthel Index of Activities of Daily Living
30 days after the incidence of SAH
National Institutes of Health Stroke Scale
30 days after the incidence of SAH
Other Outcomes (1)
Noradrenalin need
30 days after the incidence of SAH
Study Arms (2)
Hydroxyethyl starch
ACTIVE COMPARATOR15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day.
Lactated Ringer's solution
ACTIVE COMPARATOR15-50 ml/kg Lactated-Ringer's solution was given intravenously every day.
Interventions
15-50 ml/kg Lactated-Ringer's solution was given intravenously every day until discharge.
15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day until discharge.
Eligibility Criteria
You may qualify if:
- patients with subarachnoid hemorrhage
- patients with Hunt-Hess grade I-III.
You may not qualify if:
- patients with Hunt-Hess grade IV-V.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care
Debrecen, 4032, Hungary
Related Publications (1)
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.
PMID: 32689849DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer anesthesiologist and intensive care specialist
Study Record Dates
First Submitted
February 9, 2014
First Posted
February 17, 2014
Study Start
February 1, 2013
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
February 17, 2014
Record last verified: 2014-02