HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients
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|ClinicalTrials.gov Identifier: NCT00199706|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage||Drug: 7.2% NaCl in 6% hydroxyethyl starch solution||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|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 :||April 2002|
|Study Completion Date :||October 2004|
- Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199706
|Principal Investigator:||Gunnar Bentsen, MD||Oslo University Hospital|