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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
  Purpose

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 Intervention Phase
Subarachnoid Hemorrhage
 Drug: 7.2% NaCl in 6% hydroxyethyl starch solution
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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.

Resource links provided by NLM:

Drug Information available for: Hetastarch
U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

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

Estimated Enrollment: 20
Study Start Date: April 2002
Estimated Study Completion Date: October 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199706

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

No publications provided

ClinicalTrials.gov Identifier: NCT00199706     History of Changes
Other Study ID Numbers: 2002-SAHA, S-01264
Study First Received: September 13, 2005
Last Updated: June 30, 2011
Health Authority: Norway: Norwegian Medicines Agency

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

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013