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HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients

Primary Purpose

Subarachnoid Hemorrhage

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
7.2% NaCl in 6% hydroxyethyl starch solution
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring Intracranial Pressure, Intracranial Hypertension, Hypertonic Solutions, Saline Solutions, Hypertonic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Subarachnoid Hemorrhage, source of bleeding radiologically or surgically secured Age > 18 years Mechanically ventilated Sedated Stable hemodynamics Stable intracranial pressure between 10 - 20 mmHg Exclusion criteria: - Serum sodium > 160 mmol/l

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period

    Secondary Outcome Measures

    Changes in cerebral perfusion pressure (CPP) measured as AUC
    changes in cardiac output
    intrathorasic blood volume
    extravascular lung water
    serum sodium levels during the 210 minutes trial period

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    June 30, 2011
    Sponsor
    Oslo University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00199706
    Brief Title
    HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients
    Official Title
    7.2% NaCl in 6% Hydroxyethyl Starch Versus Placebo - Effect on Intracranial Pressure and Haemodynamics in Subarachnoidal Haemorrhage (SAH) Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Oslo University Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether 7.2% NaCl in 6% hydroxyethyl starch will lower intracranial pressure (ICP) in SAH-patients with normal or moderately elevated ICP in a placebo controlled study, and to describe the haemodynamic effects.
    Detailed Description
    In the acute phase after a SAH, many patients need intensive care treatment to control the development of fatally increased intracranial pressure. One type of treatment used is osmotherapy. Traditionally mannitol has been the preferred drug, but the use of hypertonic saline solutions has gained more and more acceptance. The immediate effect seems to be equivalent or better than with mannitol, and there seem to be less adverse effects, such as hypovolemia, acute renal failure, hyponatremia, and rebound increase of ICP. Most clinical studies in patients with life-threatening increase in ICP are observational, and show a predictable effect of hypertonic saline. We wanted to strengthen our own findings from such a study by applying the same study model but with a placebo control group in patients with only moderately elevated ICP. We also wanted to document the haemodynamic effects, measuring cardiac output, intrathorasic blood volume and extravascular lung water.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Subarachnoid Hemorrhage
    Keywords
    Intracranial Pressure, Intracranial Hypertension, Hypertonic Solutions, Saline Solutions, Hypertonic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    20 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    7.2% NaCl in 6% hydroxyethyl starch solution
    Primary Outcome Measure Information:
    Title
    Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period
    Secondary Outcome Measure Information:
    Title
    Changes in cerebral perfusion pressure (CPP) measured as AUC
    Title
    changes in cardiac output
    Title
    intrathorasic blood volume
    Title
    extravascular lung water
    Title
    serum sodium levels during the 210 minutes trial period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Subarachnoid Hemorrhage, source of bleeding radiologically or surgically secured Age > 18 years Mechanically ventilated Sedated Stable hemodynamics Stable intracranial pressure between 10 - 20 mmHg Exclusion criteria: - Serum sodium > 160 mmol/l
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gunnar Bentsen, MD
    Organizational Affiliation
    Oslo University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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