HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients

Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199706
• Other study ID #: 2002-SAHA
• Secondary ID: S-01264
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: June 30, 2011
• Start date: April 2002
• Est. completion date: October 2004

Study information

• Verified date: November 2005
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Drug:
• 7.2% NaCl in 6% hydroxyethyl starch solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period
Secondary	Changes in cerebral perfusion pressure (CPP) measured as AUC
Secondary	changes in cardiac output
Secondary	intrathorasic blood volume
Secondary	extravascular lung water
Secondary	serum sodium levels during the 210 minutes trial period