HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00199706

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Subarachnoid Hemorrhage	Drug: 7.2% NaCl in 6% hydroxyethyl starch solution	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2002

Study Completion Date :

Oct 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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