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Completed

NCT Number: NCT00199706

HyperHAES Versus Placebo - Effect on Intracranial Pressure in 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.

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Key information

Conditions

Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Intracranial Hypertension Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

7.2% NaCl in 6% hydroxyethyl starch solution

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2004
First posted
Sep 20, 2005
Registry last updated
Jul 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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