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HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00199706
First received: September 13, 2005
Last updated: June 30, 2011
Last verified: November 2005
History of Changes

September 13, 2005
June 30, 2011
April 2002
Not Provided
Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period
Same as current
Complete list of historical versions of study NCT00199706 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients
7.2% NaCl in 6% Hydroxyethyl Starch Versus Placebo - Effect on Intracranial Pressure and Haemodynamics in Subarachnoidal Haemorrhage (SAH) Patients.

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Subarachnoid Hemorrhage
Drug: 7.2% NaCl in 6% hydroxyethyl starch solution
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00199706
2002-SAHA, S-01264
Not Provided
Not Provided
Oslo University Hospital
Not Provided
Principal Investigator: Gunnar Bentsen, MD Oslo University Hospital
Oslo University Hospital
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP