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
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
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
NCT ID
NCT00199706
First Posted
September 13, 2005
Last Updated
June 30, 2011
Sponsor
Oslo University Hospital
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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HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients
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