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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199706

Enrollment

Registered

2005-09-20

Start date

2002-04-30

Completion date

2004-10-31

Last updated

2011-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage

Keywords

Intracranial Pressure, Intracranial Hypertension, Hypertonic Solutions, Saline Solutions, Hypertonic

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.

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.

Interventions

DRUG7.2% NaCl in 6% hydroxyethyl starch solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period	—

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026