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Trial record 36 of 195 for:    Hemorrhage AND SAH

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
Sponsor:
Information provided by:
Oslo University Hospital

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.


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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
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 : April 2002
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period

Secondary Outcome Measures :
  1. Changes in cerebral perfusion pressure (CPP) measured as AUC
  2. changes in cardiac output
  3. intrathorasic blood volume
  4. extravascular lung water
  5. serum sodium levels during the 210 minutes trial period


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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


Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Gunnar Bentsen, MD Oslo University Hospital

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ClinicalTrials.gov Identifier: NCT00199706     History of Changes
Other Study ID Numbers: 2002-SAHA
S-01264
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: November 2005

Keywords provided by Oslo University Hospital:
Intracranial Pressure
Intracranial Hypertension
Hypertonic Solutions
Saline Solutions, Hypertonic

Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Intracranial Hemorrhages
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hydroxyethyl Starch Derivatives
Pharmaceutical Solutions
Plasma Substitutes
Blood Substitutes