HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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7.2% NaCl in 6% Hydroxyethyl Starch Versus Placebo - Effect on Intracranial Pressure and Haemodynamics in Subarachnoidal Haemorrhage (SAH) Patients.

Conditions
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Subarachnoid Hemorrhage

Intervention / Treatment
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* Drug: 7.2% NaCl in 6% hydroxyethyl starch solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 7.2% NaCl in 6% hydroxyethyl starch solution|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial Pressure, Intracranial Hypertension, Hypertonic Solutions, Saline Solutions, Hypertonic