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

NCT02064075 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2014-02-17

No results posted yet for this study

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.

Conditions

  • Subarachnoid Hemorrhage

Interventions

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.

Sponsors & Collaborators

  • University of Debrecen

    lead OTHER

Principal Investigators

  • 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

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02064075 on ClinicalTrials.gov